Background: Spontaneous or postoperative gastrointestinal defects are still life-threatening complications with elevated morbidity and mortality. Recently, endoscopic treatment options – up and foremost endoscopic vacuum therapy (EVT) – have become increasingly popular and have shown promising results in these patients. Methods: We performed an electronic systematic search of the MEDLINE databases (PubMed, EMBASE, and Cochrane) and searched for studies evaluating endoscopic options for the treatment of esophageal and colorectal leakages and/or perforations until March 2022. Results: The closure rate of both esophageal and colorectal defects by EVT is high and even exceeds the results of surgical revision in parts. Out of all endoscopic treatment options, EVT shows most evidence and appears to have the highest therapeutic success rates. Furthermore, EVT for both indications had a low rate of serious complications without relevant in-hospital mortality. In selected patients, EVT can be applied without fecal diversion and transferred to an outpatient setting. Conclusion: Despite multiple endoscopic treatment options, EVT is increasingly becoming the new gold standard in endoscopic treatment of extraperitoneal defects of the upper and lower GI tract with localized peritonitis or mediastinitis and without close proximity to major blood vessels. However, further prospective, comparative studies are needed to strengthen the current evidence.

Leakages of the gastrointestinal (GI) tract are associated with detrimental consequences for the respective patient [1-5]. Those damages may occur spontaneously, after local diagnostic and interventional measures, as well as after surgery [4-6]. Consequently, those leaks lead to bacterial migration from endoluminally toward the surrounding space, thereby causing local inflammation and infection, abscess cavities, or even systemic septic complications [2, 3, 7-10]. Due to the serious morbidity and mortality that these conditions imply GI leaks represent highly relevant afflictions for the physician in charge.

Here, postsurgical complications, such as anastomotic leaks (AL) and Hartmann stump leaks, are regarded very carefully, as they increase the patient’s outcome significantly [8, 11-15]. The incidence of AL ranges from 6 to 30% after colorectal surgery, and up to 18% after esophageal or gastric resection [1, 4, 8, 11, 14, 16].

During the last two decades, an obvious paradigm shift in the treatment of GI leaks, especially AL, could be monitored. Whereas surgery for perforations and anastomotic leaks was considered the only treatment option available before that time, minimally invasive, and therefore, endoscopic therapies have gained growing significance in the therapeutic armamentarium [4-6]. Especially, redo-operations for AL are associated with relevant morbidity and mortality in both the upper and lower GI tract and should hence be indicated carefully [8, 11, 17, 18]. In this connection, endoscopic vacuum therapy (EVT) plays a major role.

The concept of applying continuous, vacuum-assisted, negative pressure via a foam to complicated wounds was first described in 1993 and is performed by surgeons worldwide since the late 1990s [19, 20]. In 2001, Weidenhagen et al. [21] started to transfer the idea of negative pressure wound therapy to an endoluminal use at our department. In a first case series published in 2008 with 29 patients treated with EVT for AL after colorectal surgery, a 97% success rate could be described. Since then, various commercial systems have been developed and are now in regular use in over 40 countries [22-25]. In the meantime, EVT is applied successfully in both upper and lower GI tract and is now considered the standard treatment for postoperative surgical leaks in many surgical departments [4, 5, 26].

The main principles of EVT are continuous or intermittent suction which leads to decreased bacterial contamination, secretion, and local edema [6, 26]. Furthermore, perfusion of the vulnerable tissue and therefore granulation is promoted [6, 26]. Thus, defects within the GI tract are closed and inflammation is attenuated.

However, clear guidelines for indication, implementation, and termination of EVT or any other endoscopic treatment options are lacking [25]. To provide an overview of the current evidence of endoscopic treatment options of GI leakages and therefore foster understanding and their application, we performed a literature review – with a clear focus toward EVT.

Until March 2022, literature review of the endoscopic treatment options for GI leakages was performed. A total of 8,472 articles could be retrieved. The most cited, representative articles with full-text access in PubMed, Embase, and Cochrane database were selected. The analysis included only English and German texts. The search criteria were keywords and their combinations: GI leakage, endoscopic treatment, endoscopic vacuum therapy, endoscopic negative pressure therapy, endosponge, endoluminal therapy, and endo-vac. The cross-searching method for the respective texts was applied. The remoteness of the available text was not taken into consideration. The inclusion criteria were as follows: well-known cited authors, major scientific journals, article views, and relevance to the request. Works in other languages than English or German were excluded from the study, as well as works not relevant to the research topic. Hereby, 98 relevant articles were examined more thoroughly and included in this review. Due to the study design, no approval by the Institutional Review Board was necessary.

Implementation of EVT

Usually, a GI leakage is detected via gold-standard endoscopy and/or computed tomography (CT) [5]. Most authors promote combining both diagnostic entities, as early and smaller insufficiencies might be detected only endoscopically but not via multi-slice imaging [5, 27, 28]. On the other hand, small wall defects might conceal major abscess cavities, referred to as the “tip of the iceberg” phenomenon [5]. These can otherwise be detected in full extent by CT scans.

Different methods of EVT-sponge placements are factually performed, yet most departments implement EVT as described by our department before [21, 22, 26]: When EVT treatment is indicated, an open-cell, microporous, polyurethane sponge is placed via flexible endoscopy and an overtube toward the respective GI defect after local endoscopic lavage. The sponge can be placed intraluminally or, in case of major abscess cavities, intracavitary. Combination of both is possible, as well as switch from intracavitary to intraluminal during treatment sequence [24]. Multiple sponges can be applied to fill the cavity. Consequently, negative pressure of −25 up to −125 mm Hg is applied to the sponge via an evacuation tube connected to either a vacuum bottle or an electronic pump [29]. In upper GI use, rather moderate negative pressures are recommended, whereas in extraperitoneal, lower rectal use, more intense suction might be applied [5, 26]. Sponge changes are usually performed endoscopically every 2–4 days [24, 26]. In transanally applied EVT, usually no or just a limited amount of sedation is required [26]. The amount of sedation for transesophageally placed sponges is approximately equal to the amount used during regular esophagogastroduodenoscopy [6, 30].

EVT for Anastomotic Leakages after Colorectal Surgery

Colorectal EVT is up- and foremost applied due to ALs (68%), followed by rectal stump leaks (20%), as spontaneaous, traumatic, or iatrogenic perforation accounted for not more than 3% of all EVT patients [25, 26]. The underlying disease for EVT in majority of all cases (65%) is colorectal carcinoma [25].

A recent meta-analysis from our department comprises 24 studies with 690 patients treated with EVT for AL after colorectal surgery [4]. This represents the largest body of evidence for EVT so far. As a result, EVT is described as a feasible treatment option with low, manageable risk for selected patients with colorectal leaks [4]. However, there are still no RCTs available, and the included studies are only retrospective and prospective observational studies.

A weighted mean rate of successful EVT was reported in 81.4% of all patients [4]. This is in accordance with the earlier systematic reviews which describe an EVT success rate of 54–96% [22].

Fecal diversion was applied in 76.4% of all patients [4]. Some authors describe success rates of EVT to be up to 30% higher than after the respective conventional treatment, defined as drainage, draining relaparotomy, diverting ileostomy, anastomotic resuturing, or resection of the anastomosis with Hartmann’s procedure [24].

Ostomy reversal rate after EVT for colorectal defects was 66.7% [4]. Taking into account that the regular stoma closure rates range from 25 to 47% after Hartmann’s procedure and 30–40% after AL in colorectal surgery, the ostomy reversal rates after EVT show even better results [7, 31-33]. Depending on the author, stoma closure tends to be performed up to 49% more frequently after EVT than after conventional therapy, yet potentially resulting in a longer in-hospital stay with EVT [24]. Time to stoma closure did not differ significantly [24].

On average, EVT sponges need to be changed 6.8 times, resulting in a mean therapy duration of 23.4 days; however, these results vary a lot as some studies report of EVT duration ranges from 11 to 253 days [4, 22]. Especially in cases of neoadjuvant radiochemotherapy (RCTx), treatment durations were found to be significantly prolonged (31.1 vs. 15.9 days), as described in smaller case series [34]. However, no changes in EVT success rates were monitored. Neoadjuvant RCTx is proposed to impair granulation, and hence healing of the surrounded tissue due to downregulation of growth factors [35]. This explains why RCTx not only prolongs wound healing but also accounts for higher rates of AL and surgical site infections per se, especially in distinctive tumor response [36, 37]. Moreover, the underlying disease out of which the GI leak resulted influences therapy duration, as benign indications account for shorter treatment periods [25].

The most common reason for EVT failure is non-responding tissue in 11.8% of all cases; therefore, approximately 10 times more frequent than any other cause for unsuccessful therapy termination [4]. Some studies evaluated risk factors for EVT failure. These contained neoadjuvant pretreatment, male sex, EVT duration of more than 21 days, multivisceral resection, and surgical revision after primary surgery [4, 38, 39]. Iatrogenic or traumatic rectal perforations showed the best therapeutic results of up to 100% [26]. Most studies suggest that EVT should be applied in patients with extraperitoneal defects, without a complete circular necrosis, in order to achieve the best outcome [4].

EVT for Rectal Stump and Ileal Pouch-Anal AnastomosisLeakages

Kühn et al. [17] also evaluated the outcome of EVT after Hartmann’s procedure which represents a cohort of seriously ill patients. Hartmann’s procedure with discontinuity resection resulting in end colostomy and rectal stump is performed in patients suffering from diverticular disease, primary or redo-operations of pelvic cancer and complication-associated operations [17]. Of note, rectal stump leakage itself represents a serious life-threatening complication, as redo-operation are associated with high perioperative risks and consecutive ostomy reversals are rare [12, 13, 15]. In the case series mentioned above, 56 patients with rectal stump leakage were evaluated and showed EVT success rates of 84% [17]. A median of 7 sponge changes was performed, leading to a median therapy duration of 20 days. Another study from Shalaby et al. [22] showed according results, yet with a longer therapy duration of 47 days. Of note, 98% of patients had an ASA score of 3–4, underlining the debilitated character of this patient cohort [17]. Complications occurred in 4% with minor bleeding, which could be endoscopically controlled. After 7 months, 21% of the patients received ostomy reversal [17]. This is notably less frequent than the median rate of stoma closure after Hartmann’s procedure in the literature with 19–71% [15, 40]. The authors discuss that this might be due to the limited follow-up period [17]. Common reasons for non-restoration of intestinal continuity after Hartmann’s operation are advanced age, high ASA score, advanced or metastatic cancer, patient refusal, and anal incontinence [12]. A case series with up to 30 patients evaluated the treatment of leaky Ileal Pouch-Anal Anastomosis. EVT was found to succeed in 100% of applied cases, therefore almost twice as often as conventional treatment (52%) [26, 41].

Is an Ostomy Necessary in Colorectal EVT?

Another publication discussed the possibility of using EVT without the need for fecal diversion [18]. This is possible in selected patients with extraperitoneal abscess cavity, in which the sponge can be placed entirely with complete sealing toward the lumen. Hence, the cavity can be sealed and no feces is aspirated by the sponge [18]. In these cases, EVT success rates of up to 90% are possible, therefore representing no difference to diverted patients [18]. Secondary fecal diversion after initiation of non-diverted EVT did not lead to local improvement or clinical deterioration [18]. As ostomy closure rates differ between not more than 51–69%, depending on the literature, EVT without ostomy should be taking into account when applicable [18, 42]. The authors suggest the applicability criteria: hemodynamically stable, clinically relevant AL, no generalized peritonitis, no intraperitoneal abscess, distance to anal verge >1 cm, sufficient anal sphincter function, intubation of the abscess cavity possible with endoscope, complete intracavitary sponge placement with sealing toward lumen, patient compliance [18]. Recent data also suggest the application of a diverting ostomy in EVT after preoperative radiochemotherapy or after late EVT initiation, due to impaired tissue healing [18, 22, 42].

Treatment of Esophageal Leakages

The Esophagectomy Complications Consensus Group (ECCG) defined ALs as defects of the entire esophagus, anastomosis, staple suture, or conduit. In this classification, leaks are divided into three types depending on the treatment [43]. Type 1 leaks require no deviation from the normal postoperative course, type 2 requires intervention but no surgery, and type 3 requires surgical therapy. Postoperative AL of the esophagus is reported to occur in up to 18% of all cases with mortality of up to 50% when experienced [8, 11, 14]. Hence, esophageal leaks represent detrimental inflictions with potentially fatal courses. Other causes for esophageal discontinuity are during endoscopy (30–83%), spontaneous rupture (5–56%), trauma (0–14%), foreign bodies (0–35%), and tumors (0–5%) [30].

There is growing evidence on the advantages of applying EVT for esophageal leakages [6, 30, 44]. Beginning in 2010, EVT has now been used regularly for defects in the upper GI tract, up- and foremost for esophageal AL [45-48]. In 2015, Kühn et al. [44] confirmed EVT as a promising approach for the treatment of postoperative, iatrogenic, or spontaneous lesions of the upper GI tract in a patient series of 21 patients. EVT has ever since been increasingly used as an isolated therapy or as part of a more complex approach to esophageal salvage in combination with conventional surgery to control mediastinal or pleural sepsis [30]. Case reports indicate successful EVT therapy after iatrogenic perforation, caused by stiff endoscopy, as well as after spontaneous esophagus ruptures, like in Boerhaave’s syndrome [44]. Even cases of perforation after colliquative necrosis due to ingestion of noxious agents can successfully be treated by EVT [49]. In total, success rates of up to 90% are described, in cases of immediately treated perforations even up to 96% [6, 30].

Schniewind et al. [14] reported the largest series comparing EVT with other procedures for the treatment of leakage after esophagectomy and showed EVT to be superior to surgical revision, stent implantation, and conservative treatment. A recently conducted systematic review and meta-analysis which comprised 4 studies with 71 patients treated with EVT compared to 92 patients treated with self-expanding covered metal stents (SEMS) showed that the esophageal leak closure rate was significantly higher with EVT than with stent implantation (odds ratio 5.51) [50]. In addition, compared with stent therapy, EVT had a shorter treatment duration (mean −9.0 days). Moreover, EVT has a lower rate of serious complications and a lower in-hospital mortality rate [50, 51]. Furthermore, some studies report on promising results in combining EVT with other local treatment options like over-the-scope clips or SEMS [14, 45, 52].

Nonetheless, luminal stents are still in everyday use in multiple departments when treating leakages of the upper GI tract [53]. These stents are self-expandable, can be made of polyester or metal, and are either fully or partially covered (if metal) [54, 55]. Their rationale is covering of the defective site and diverting luminal content, therefore promoting mucosal wall healing. Hence, complete drainage of any extra-luminal collection is obligatory, in order to prevent septic complications [56, 57]. One of the major advantages of luminal stenting is the possibility of oral intake during treatment [56]. On the other hand, treatment periods are usually quite long and range from 5 to 10 weeks [58]. Overall closure rates of AL range up to 76.8%, with even higher closure rates for postsurgical leaks (81.4%) [55, 59]. However, the application of GI stents is associated with relevant rates of complications of up to 72% and mortality rates of up to 28%, yet still being lower than mortality rates of surgical redo-operations [55, 59, 60]. The most common stent-associated complications include tissue overgrowth (41–53%), potentially resulting in stenosis, stent migration, esophageal rupture, hemorrhage, and ruptured stent cover [56].

In contrast to colorectal leaks however, EVT and esophageal surgery are often referred to as working complementary within the upper GI tract [30]. Some authors promote the concept of surgical drainage of the pleura, mediastinum or even the abscess cavity and simultaneously treating the GI defect with EVT [30].

Other Fields of EVT Application

Most evidence for EVT has been gained for treating colorectal and esophageal leakages. However, single-center reports exist for regular use of EVT for duodenal leakages and suture insufficiencies after bariatric surgery [61-63]. This was described as therapeutically superior to gastric stenting. Moreover, single case reports indicated that EVT could even be successfully applied to pancreatico-gastric AL, yet not representing current standard in the broad clinical mass [64].

EVT Initiation and Planned Therapy Termination

EVT should be initiated in close temporal proximity to the diagnosis of the leak [65]. That is because late secondary EVT start is associated with significantly impaired therapy outcome. For example, one study showed a success rate of not more than 27.8% when applied more than 15 days after diagnosis. Other authors report of adequate success rates when EVT is applied within 6 weeks; however, local intensive cleansing and debridement prior to EVT is suggested [25, 65].

The degree of anastomotic disruption up to which EVT can safely be performed is discussed controversially. Most recent reports tend to broader indications of more than half of the circumference, if not completely necrotic [4, 18, 66]. During the treatment phase, no regular CT or MRI controls are needed, endoscopic lavage and assessment suffice during therapy. Factors that factually influence the decision-making process in treatment of GI leakages are general condition of the patient, degree of anastomotic disruption, extent of infectious reaction and spread, ischemia of the neorectum/esophagus, presence of fecal diversion and urgent chemotherapy [66].

EVT can be regarded as successful, when 90% of the cavity or the defect is closed replaced by clean granulating tissue [25]. In this case, no further interventional or surgical treatment is expected, so that EVT can be safely terminated. EVT failure is defined by local or clinical/systemic deterioration, which in 72% of all cases happens due to insufficient granulation with persistent sepsis [25]. Only 8% of all patients terminate EVT upon personal demand [25].

Preemptive Use of EVT

Some authors have already described regular preemptive use of EVT without visible AL, up- and foremost in treating esophageal anastomoses [29, 67, 68]. Especially in cases of so-called “at-risk” anastomoses, this might hinder the development of a “true” AL [69, 70]. In case series with up to 67 patients, good results with AL rates of 7.5% could be achieved, which was therefore lower than the regular esophageal AL rate in the literature [69, 70]. Visible sutures or staples, ulceration or perfusion deficit define “at-risk” anastomoses in the esophagus [69, 70]. Müller et al. [69] even promote the concept of applying EVT directly after esophageal resection for 4–6 days. Loske et al. [70] suggested the preemptive use of EVT in order to evacuate reflux from the anastomotic region as this is believed to relevantly contribute to development of upper GI AL. Important data for regular use of preemptive EVT in colorectal setting is lacking; however, some centers report to apply on an irregular basis [71, 72].

Socioeconomic Considerations

A recent study described transanal EVT as a feasible treatment option in an outpatient setting, in order to shorten in-hospital stay and reduce health economic costs [25]. 49% of 281 included patients were treated in an ambulatory setting with EVT success rates of 91% [25]. In 5 patients, EVT was initiated in an outpatient setting with 100% success rates [25]. Even 45% of rather ill patients with rectal stump leakage could be transferred to an outpatient setting with regular ambulatory sponge changes [17]. A total of 46% of the overall EVT duration could be reduced in-hospital and performed as outpatient treatment [25].

Performing fecal diversion leads to significantly higher overall costs [73, 74]. In cases of colorectal EVT treatment without fecal diversion, approximately USD 9,000 could be saved per patient case as calculated according to German healthcare costs [18]. Moreover, patient-reported life quality is improved significantly when an ostomy can be avoided [18].

EVT Complications

Regarding potential complications caused by EVT, there are heterogeneous data in the literature. The meta-analysis for colorectal leaks of our department revealed a complication rate of 12.1% [4]. Yet, the majority of these complications was easily manageable, mostly by endoscopic means. The most frequent complications were stenosis (0–18.2%), followed by fistulas (0–28.6%), and occasional bleeding (0–9.7%) [4]. No mortality was so far reported directly related to EVT in lower GI use [4]. Stenosis was regarded in both patients with or without fecal diversion to the same extent and was completely reversible by balloon dilatation in most patients [18, 22]. The majority of patient that developed fistulas had multivisceral resections including the uterus and vagina prior to developing AL [25].

In upper GI use, stenosis and strictures have also been reported on after EVT in 3–14% of all cases, yet also resolved completely after endoscopic dilatation [6]. A very rare, yet dreadful complication in upper GI application of EVT is hemorrhage by fistula development to adjacent major blood vessels [6]. Therefore, authors suggest EVT in the upper GI tract only after respective imaging and after excluding the presence of these vessels in close proximity to the defect [6].

Over the last two decades, endoscopic treatment options for GI leaks have developed to become the prime choice for treatment of local wall defects, potentially including abscess cavities, excluding generalized peritonitis/mediastinitis [5, 26]. EVT has hereby been proven to be therapeutically superior to other local treatment options and in selected cases even to open surgery [4, 5]. By omitting major perioperative risks that surgical revisions might imply, EVT is preferably used by many surgeons and endoscopists worldwide [25, 26, 38, 39, 65, 75-91]. Even though the best results have been described for immediate therapy of iatrogenic, spontaneous, or traumatic perforation, EVT is in the meantime regarded as the gold standard for treating AL [4, 5].

AL after esophagectomy remains a serious postoperative complication that is potentially life-threatening to the patient [8, 11, 14]. Due to its mortality rates of up to 50% and its significant morbidity when revised by open surgery, quick initiation of EVT – sometimes even in preemptive settings – is nowadays part of the standard armamentarium in esophagus-resecting departments [8, 11, 14]. Rectal ALs also represents a dreaded complication after colorectal resection with oncological, functional, and financial consequences, as well as risk for sepsis and impaired overall outcome [1, 2, 42, 92, 93]. Mean postoperative AL rates are described in ranges from 6 to 30% with an average of 11% and are therefore not uncommon [1, 16]. They mostly occur in male and overweight patients, post RCTx and within the lower half of the rectum [10, 94]. In the pre-EVT era, almost every patient included in this review would have undergone major abdominal (redo-) surgery for the respective GI leakage, therefore experiencing a higher risk for morbidity and mortality [18]. In contrast, current treatment options in colorectal leaks even allow minimally invasive EVT without performing fecal diversion, even though factually a diverting ostomy is still applied in most cases of left-sided AL of the colorectum, as done so by the surgeon’s individual decision. This leads to ostomy rates in EVT patients of up to 93% [25]. However, there is little evidence of the influence of fecal diversion in treatment of anastomotic leakages; yet, some authors discuss technical problems, such as sponge dislocation, in EVT without diverting ostomy.

Of note, this review focusses on the very well described evidence of EVT in GI leakages. EVT represents the standard treatment for postoperative surgical leaks in many surgical departments, foremost in Europe [25, 26, 38, 39, 65, 75-91]. Minimally invasive alternatives for AL, such as stents, clips, and fibrin glue, are limited to very small leaks without major cavities [31, 94, 95]. Furthermore, success rates of these measures still remain uncertain as only few studies with limited patients exist. Of these, stenting has the most data available with sometimes promising results [94, 96]. Success rates of 73.3% have been reported in selected patients [94, 96]. Currently, it is the upper GI tract and AL after bariatric surgery in which stents are regularly used [53-55]. However, patient selection is even more restricted than for EVT and stenting is associated with high migration rates and reported side effects of discomfort and tenesmus [94]. Furthermore, most of the data regarding GI defect treatment with SEMS derives from cohorts with spontaneous or iatrogenic ruptures and fistulas, as AL cohorts are underrepresented [54-56, 59, 60]. Especially in the lower GI tract, the clinical role of stent application is shrinking as migration rates reach up to 80%, resulting in insufficient treatment results and patient discomfort [55]. Even in the upper GI tract stent-related complications occur in up to 72% of the cases with a respective mortality of up to 28% [55, 59, 60]. In order to further elucidate and compare the therapeutic outcomes of EVT and stenting in upper GI leakages, a multicentric, prospective, randomized study is currently conducted in Germany [97]. Compared to conventional, mostly surgical treatment of AL, EVT seems to be more effective in terms of definite healing and ostomy reversal, yet possibly resulting in longer in-hospital stay [24]. However, there is growing evidence that EVT can be transferred to an outpatient setting when selected properly [25, 26].

There are several factors that can improve the outcome. Early initiation of therapy appears to be associated with faster recovery and a higher success rate [65]. Early initiation of treatment should, in theory, prevent the development of a chronic presacral abscess [79, 80, 86]. Since, this complication often leads to failure of EVT due to chronic sepsis and increasing fibrosis. One study was able to show that an age >60 years also has a negative influence on the prolongation of treatment [38].

The major limitation in evaluating current EVT studies is the lack of high-quality data as no randomized controlled trials exist so far [4]. This is emphasized in the meta-analysis for colorectal leaks from our department, delivering the best evidence possible at the moment [4]. Only few large observational studies manage to deliver qualitative results [25, 39]. Most of the data derive from case reports and series [75, 76, 79, 83, 88, 98]. Moreover, data quality is impaired by the mostly retrospective character of current studies [4]. Therefore, the conclusions drawn from these studies and being displayed in this article should be interpreted with care. Critics also mention worries about the lack of long-term AVT failure data [42]. However, most recent studies trend toward significantly higher success rates and lower complication rates than studies in previous years [22, 24, 25, 99].

Another drawback of EVT application is the need for creative adaptation [5]. Whereas, SEMS exist in ready-to-use formats for multiple years, a certain amount of handicraft work is necessary in order to apply EVT sponges correctly [5]. Moreover, specific EVT vacuum pumps do not exist up until now [5].

The long duration of therapy is an additional problem of EVT. Reported treatment durations from up to 253 days can only be limited to individual cases [4]. Furthermore, there is huge heterogeneity between several studies when it comes to treatment duration [4, 22]. This might be due to the fact that clear guidelines for therapy duration and termination are still lacking. Proposed findings like replacement of 90% of the cavity or the defect by clean granulating tissue might be helpful for endoscopists to opt for termination [17, 25]. In addition, EVT is associated with comparatively high costs. Basically, this depends on the respective healthcare system. Some authors reported a cost calculation, e.g., 3,125 EUR per case in Italy [80], while a Dutch study calculated 8,933 EUR per case [86]. Kühn et al. [18] calculated EVT alone at 6,027 EUR.

An advantage of EVT treatment compared to surgical alternatives is the possibility to transfer a patient to an outpatient setting [25]. In fact, Kühn et al. [25] 2020 reported an outpatient cohort in which inpatient treatment duration could be reduced by a median of 15 days, which was 46% of the total EVT duration; the results here were excellent with 98% healing [25]. In 5 patients, even a complete outpatient EVT therapy could be established with a 100% success rate [25]. Beside the positive effect that an ambulatory treatment might improve the patient’s quality of life, significant cost reductions for the healthcare system come along. Combining EVT without fecal diversion, a sum of 7,700 EUR might be saved per case [18].

Although EVT has a good safety profile with a median complication rate of 12% [4]. This should still be considered in any therapy initiation. In the recently published meta-analysis by Kühn et al. [4], 2021, anastomotic stenosis represented the majority of complications with n = 24 cases. However, this complication is usually sufficiently treatable with endoscopic balloon dilatation, therefore not requiring further surgical intervention [4, 18, 22]. Furthermore, relevant percentages of postoperative stenosis are also known in conservative and conventional treatment due to local inflammation [100].

Another limitation of the displayed studies is the predominant focus on endoscopic anastomotic salvage and ostomy reversal rates. Almost no study provides specific quality of life analysis. This seems somewhat remarkable as patients suffering from GI leaks show a relevantly higher prevalence of impaired functional and mental outcome [94, 101-103]. There are only few studies including functional outcome as a defined secondary outcome [42]. However, most of these studies report post-EVT stool function to be satisfactory [38, 41, 76, 79]. Yet, some authors describe higher numbers of bowel movements after EVT, with a median of 8 per day and 1.7 per night [88]. Critically, one could assume that prolonged EVT might contribute to low anterior resection syndrome (LARS), a description of functional impairment after respective lower rectal resection resulting in unfavorable changes in stool frequency, consistency, urge, evacuation, and incontinence with hence lowered quality of life [104-107]. Even though high-quality studies correlating LARS to EVT are still lacking, one of the major pathophysiological mechanisms facilitating LARS can also be supposed for EVT: lowered compliance of the (neo-)rectum [107]. As granulation is promoted by EVT, a certain fibrotic conversion of the rectum might be discussed which would in this case lead to impaired rectal compliance. Nonetheless, there are no results clearly attributing LARS to EVT until now, as AL itself is a clearly defined risk factor for LARS [104, 106, 107]. Furthermore, satisfactory results in functional outcome could also be explained by already impaired pre-EVT stool function. In future, prospective studies evaluating EVT should focus more on patient-reported outcomes, in order to further elucidate the EVT-LARS-correlation.

EVT is currently applied in more than 40 countries [22-24]. However, the USA still do not use EVT regularly outside of study settings, as it is not approved by the FDA. In Europe, EVT is yet regarded as a standard treatment for GI leaks as most of the relevant studies derive from Italy, Germany, or The Netherlands [4]. The reservation of specific healthcare systems to apply EVT in a broader setting might be explained by deficient prospective study data and a potential overinterpretation of EVT’s complication profile.

Because of the positive results endoscopic treatment options for GI leakages have achieved within recent years, new therapeutic inventions have entered the market for endoscopic application: Double-layer, open-pore film drainages are in use to evacuate secretion firmly sticking to the surrounding tissue [108]. The attempt to combine stenting and EVT has also already been successfully tested in small case series in stent-over-sponge (to completely seal a drained cavity toward the lumen) and sponge-over-stent (to ensure passage while applying negative pressure) models [109, 110].

Certain treatment algorithms should be followed, in order to maintain EVT’s convincing therapeutic results and limit its complication and treatment failure profile to a minimum [26]: EVT can successfully be applied in extraperitoneal defects in the upper and lower GI tract with localized peritonitis or mediastinits and without close proximity to major blood vessels. Generalized peritonitis/mediastinits, intra-abdominal abscesses, or clinically instable patients should be treated by surgery. Diverting ostomies might be omitted in selected patients with rather large abscess cavities. The transferal of patients to an ambulatory setting is possible and leads to improved quality of life in patients and reduced costs in healthcare systems. Therefore, endoscopic treatment options – especially EVT – have become safe and feasible therapeutic alternatives to surgery in GI leakages with excellent outcome and limited morbidity. However, prospective evaluation of the evidence gained solely by retrospective and observational studies is still lacking and should be performed by randomized controlled trials in the near future.

The authors acknowledge the outstanding and trend-setting previous works of Rolf Weidenhagen and Gunnar Loske and the contribution they made for developing and implementing EVT in a standardized clinical setting.

An ethics statement was not required for this study type, no human or animal subjects or materials were used. Only review of publicly available literature was performed.

The authors have no conflicts of interest to declare.

None of the authors received any funding from any sponsor relevant to either content or preparation of this manuscript.

Moritz Drefs and Florian Kühn concepted, designed, and drafted the manuscript; acquired, analyzed, and interpreted the data; gave final approval; and agreed to be accountable. Josefine Schardey, Viktor von Ehrlich-Treuenstätt, Ulrich Wirth, Petra Zimmermann, Maria Burian, and Jens Werner analyzed and interpreted the data, revised the manuscript critically, gave final approval, and agreed to be accountable.

All data analyzed during this study derive from the publicly available literature. All respective references containing these data are included in this article’s “references” section. Further inquiries can be directed to the corresponding author.

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