Introduction: Patients with Crohn’s disease (CD) require an assessment of small bowel lesions, while difficulties exist in performing small intestinal examinations, especially in small-sized medical offices. Small bowel capsule endoscopy (SBCE) is handy and can be performed in most clinical settings. The only drawback of SBCE is a requirement of patency testing prior to the exam because it sometimes requires CT scanning to localize the ingested patency capsule (PC), which may be a substantial burden for the patient. We have developed a novel PC detection system named PICS (patency capsule, ileocolonoscopy, and small bowel capsule endoscopy) method by which we can avoid CT scanning. In the PICS method, ileocolonoscopy (ICS) is performed after 30–33 h of PC ingestion and the PC can be localized by ICS in patients who have not excreted the PC, and the entire intestine can be examined in combination with subsequent SBCE without additional bowel preparation. The aim of this study was to assess the usefulness and safety of the PICS method for CD patients. Methods: CD patients who underwent PICS method from April 2021 to March 2023 were reviewed for clinical data, outcome of PICS method including the rates of PC detection by ICS, the number of patients underwent SBCE, and adverse events. Lewis score was used to assess SBCE results. Results: The PICS method was performed in 54 patients. The median age of patients was 28.5 years old, and 64.8% of them were ileocolic type. The median disease duration was 10.5 months and 24.1% had history of small bowel resection. Five cases (9.3%) confirmed gastrointestinal patency by ICS, and none of the cases required CT scanning. One patient who could not be confirmed patency by ICS, and the other patient who excreted PC but was found ileal stenosis by ICS did not undergo SBCE. Remaining 52 patients received SBCE, and the median Lewis score of them was 0 (IQR 0, 450). There were no adverse events including small bowel obstruction by PC and SBCE retention in this series. Conclusion: The PICS method is not only feasible and safe but also convenient to assess disease extent in patients with CD. By localizing PC with ICS, additional CT scanning could be unnecessary for SBCE, which benefits both physicians and CD patients.

More than half of the patients with Crohn’s disease (CD) have small bowel involvement [1, 2]. Early detection of the small bowel involvement is important in the management of CD patients because extensive small bowel disease is one of the risk factors of unfavorable prognosis [3, 4]. Lack of a standard method to evaluate small bowel lesions has made planning of CD treatment difficult, although various methods to assess the small intestine have been applied; i.e., small bowel capsule endoscopy (SBCE), device assisted endoscopy (DAE), small bowel follow through (SBFT), magnetic resonance enterography (MRE). Among them, SBCE was first described in 2000 [5], and approved by Food and Drug Administration in 2001. It is thought to be suitable for patients with asymptomatic or mild CD because of its superior tolerability and diagnostic accuracy in the detection of small lesions to other types of exam [6]. In addition, it requires only a few medical resources. Therefore, SBCE may be the best method to evaluate the small bowel involvement of CD in a setting of small-sized facility where clinically quiescent CD patients are often seen.

Capsule retention is one of the few complications of SBCE, and the rates of it in suspected and established CD have been reported 3.32% and 4.63%, respectively, which are considered higher than the rate of such complication in other small bowel disorders [7‒11]. This may be due to anatomical deformity of the intestine often seen in CD patients caused by a previous surgery, adhesion, inflammation, and fibrotic changes, stenosis, and narrowing of the intestinal lining. The diagnostic value of patency capsule (PC) testing for capsule passing before SBCE application has been reported [12, 13]. Evidence from Japanese multicenter trial has also confirmed that the PC testing may reduce the risk of capsule retention in both suspected and established CD patients [14]. Based on these findings, SBCE was approved in Japan for CD patients who were confirmed gastrointestinal (GI) patency by PC testing. European Society of Gastrointestinal Endoscopy has also recommended PC testing prior to SBCE in established CD patients [6]. GI patency is confirmed when PC is excreted as an intact form within 33 h of ingestion. When PC is not excreted in this time frame, the localization and the form of the PC are normally assessed by plain X-ray. However, it is often difficult to determine the actual location of the PC by plain X-ray [15], and an evaluation by computed tomography (CT) may be needed in up to 13.7% of the cases [14]. This may be a significant hindrance for applying SBCE to CD patients. We therefore thought that establishing a CT-free, easy, and accurate method to detect PC location would make SBCE more useful in the management of CD, especially in the setting of a small-sized facility that does not have a CT scanner.

It is reasonable that the patients with CD should be examined both the small bowel and the colon every several years, because the disease location may sometimes be extended [16]. We have experienced easy detection of PC by ileocolonoscopy (ICS) in CD patients who do not excrete PC after 33 h of PC ingestion. Subsequent SBCE allows us to examine both of the small bowel and the colon together in one preparation. We named this method PICS (patency capsule, ileocolonoscopy, small bowel capsule endoscopy) method and have used to assess GI lesions in patients with CD since April 2021. The PICS method may solve many problems of GI patency confirmation including the on demand requirement of CT and misdiagnoses of PC location. In the present study, we assessed the usefulness and safety of the PICS method to evaluate the small and large intestinal lesions in patients with quiescent and mildly active CD. Establishing an easier, safer, and more accurate method to evaluate small bowel lesions in patients with CD will significantly raise the quality of care in the management of CD patients.

Patients

We conducted a case series study in patients with clinically mild CD who were evaluated small intestinal lesions by PICS method in our facility from April 2021 to March 2023. Cases were identified by using Solemio endoscopy management software (Olympus Medical Systems, Tokyo, Japan) with the term “small bowel capsule endoscopy.” Patients’ demographics and characteristics including age, sex, disease duration, and history of small bowel surgery were manually obtained from the electric medical records. The disease location was classified according to the Montreal classification [17]. Patients with ileal or colonic stoma, history of gastric surgery, without adequate data or sufficient evaluation of GI patency were excluded. The outcome of PICS method including the rates of PC detection by ICS, the requirement of CT to localize PC, and the number of patients underwent SBCE, and adverse events were evaluated. The results of SBCE were expressed by the Lewis score [18].

The PICS Method

PICS method was performed in CD patients according to the protocol shown in Figure 1. Briefly, the patients took following steps: (i) Patients ingested PC early in the morning of the day before (30–33 h before) the exam, then took laxative (24 mg of Sennosides) at night if needed. (ii) Next day (the day of exam), patients took 2,000 mL of PEG. (iii) Patients who did not confirm PC excretion in 33 h took X-ray in order to exclude the possibility of unrecognized PC excretion (Fig. 2a). (iv) ICS was performed and the localization of PC was assessed while examining colonic lesions (Fig. 2b–d). (v) SBCE was ingested subsequently after ICS (Fig. 2e). The timeline of the PICS method is listed in Table 1.

Fig. 1.

The flowchart of the PICS method. Patients who could not confirm patency capsule (PC) excretion took plain X-ray to see if the PC remained in the body. Patients who reported PC excretion or was confirmed absence of PC in their body by X-ray underwent ileo-colonoscopy (ICS) followed by small bowel capsule endoscopy (SBCE). Those who detected PC by plain X-ray received ICS to evaluate gastrointestinal patency.

Fig. 1.

The flowchart of the PICS method. Patients who could not confirm patency capsule (PC) excretion took plain X-ray to see if the PC remained in the body. Patients who reported PC excretion or was confirmed absence of PC in their body by X-ray underwent ileo-colonoscopy (ICS) followed by small bowel capsule endoscopy (SBCE). Those who detected PC by plain X-ray received ICS to evaluate gastrointestinal patency.

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Fig. 2.

A representative case of PICS method. A patient status post-ileocecal resection. a Plain X-ray shows patency capsule (PC) in right lower abdomen. b–d PC was found at the vicinity of ileocolic anastomosis. The PC just came out from the ileum passing through the anastomosis observed by ileocolonoscopy (ICS). e Small bowel capsule endoscopy (SBCE) was safely performed subsequently to ICS.

Fig. 2.

A representative case of PICS method. A patient status post-ileocecal resection. a Plain X-ray shows patency capsule (PC) in right lower abdomen. b–d PC was found at the vicinity of ileocolic anastomosis. The PC just came out from the ileum passing through the anastomosis observed by ileocolonoscopy (ICS). e Small bowel capsule endoscopy (SBCE) was safely performed subsequently to ICS.

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Table 1.

Schedule of the PICS method

Day 0 7:00 PC ingestion 
At night Take Sennoside (optional) 
Day 1 At morning Take 2 L of polyethylene glycol (PEG) 
12:00–13:00 Plain X-ray if patient has not noticed PC excretion 
13:00–14:00 Ileocolonoscopy, evaluate the colon and the localization of PC 
14:00–15:00 Ingestion of SBCE, leave the hospital 
15:30–16:00 Permit to drink water 
18:30–19:00 Permit to take foods 
22:00–22:30 Recorder removal before taking a bath 
Day 2  Patient visit the hospital and return the recorder 
Day 14-  Plain X-ray if the patient has not noticed SBCE excretion 
Report of the SBCE results at next visit 
Day 0 7:00 PC ingestion 
At night Take Sennoside (optional) 
Day 1 At morning Take 2 L of polyethylene glycol (PEG) 
12:00–13:00 Plain X-ray if patient has not noticed PC excretion 
13:00–14:00 Ileocolonoscopy, evaluate the colon and the localization of PC 
14:00–15:00 Ingestion of SBCE, leave the hospital 
15:30–16:00 Permit to drink water 
18:30–19:00 Permit to take foods 
22:00–22:30 Recorder removal before taking a bath 
Day 2  Patient visit the hospital and return the recorder 
Day 14-  Plain X-ray if the patient has not noticed SBCE excretion 
Report of the SBCE results at next visit 

PC, patency capsule; SBCE, small bowel capsule endoscopy.

Devices

ICS was performed by using CF-H290I or PCF-PQ260I (Olympus Medical Systems, Tokyo, Japan). Tag-less PillCam™ PC (product number FGS-0109-j; Medtronic, Minneapolis, MN, USA) was used to assess GI patency. SBCE was performed by using PillCam™ SB3 (Medtronic, Minneapolis, MN, USA).

Statistical Analysis

Descriptive statistics were performed by using GraphPad Prism 8.0 (GraphPad Software Inc., San Diego, CA, USA).

Patients

A total of 54 CD patients underwent PICS method during the study period. During the preparation of PICS method, 52 out of 54 patients took Sennoside.

Patients’ demographics and characteristics are shown in Table 2. Most patients were male (90.7%). Median age of the patients was 28.5 years old (IQR 20.0, 35.0), and 64.8% of them were ileo-colonic type. Screening abdominal X-ray was taken in 49/54 (90.7%) of the patients within 3 months before the exam. The median disease duration was 10.5 months (IQR 3.75, 41.0), and 24.1% of the patients had history of small bowel surgery. The median CDAI and serum CRP levels of the patients were 39.15 (IQR 19.58, 76.0) and 0.2 mg/dL (IQR 0.1, 0.625), respectively.

Table 2.

Background of the patients underwent PICS method (n = 54)

Male, n (%) 49 (90.7) 
Age, years, median (IQR) 28.5 (20.0, 35.0) 
Outpatient, n (%) 49 (90.7) 
Location of disease, n (%) 
 L1 9 (16.7) 
 L2 10 (18.5) 
 L3 35 (64.8) 
Plain X-ray within 3 months, n (%) 49 (90.7) 
Disease duration, months, median (IQR) 10.5 (3.75, 41.0) 
History of small bowel surgery, n (%) 13 (24.1) 
CDAI, median (IQR) 39.15 (19.58, 76.0) 
CRP, mg/dL, median (IQR) 0.2 (0.1, 0.625) 
Male, n (%) 49 (90.7) 
Age, years, median (IQR) 28.5 (20.0, 35.0) 
Outpatient, n (%) 49 (90.7) 
Location of disease, n (%) 
 L1 9 (16.7) 
 L2 10 (18.5) 
 L3 35 (64.8) 
Plain X-ray within 3 months, n (%) 49 (90.7) 
Disease duration, months, median (IQR) 10.5 (3.75, 41.0) 
History of small bowel surgery, n (%) 13 (24.1) 
CDAI, median (IQR) 39.15 (19.58, 76.0) 
CRP, mg/dL, median (IQR) 0.2 (0.1, 0.625) 

SBFT, small bowel follow through; CDAI, Crohn’ disease activity index.

CT Scanning Was Not Required in PICS Method

Methods used to confirm GI patency were shown in Figure 3. None of the cases in PICS method required CT. Instead, 5 cases (9%) of the patients confirmed GI patency by endoscopically observing an intact body of PC in the large intestine during ICS.

Fig. 3.

Method used to confirm gastrointestinal (GI) patency. None of the cases required computed tomography (CT) evaluation. Nine percent of the PICS method confirmed GI patency by ileocolonoscopy (ICS). Plain X-ray was used only to check whether patency capsule (PC) was still in the body or had been excreted already without notice.

Fig. 3.

Method used to confirm gastrointestinal (GI) patency. None of the cases required computed tomography (CT) evaluation. Nine percent of the PICS method confirmed GI patency by ileocolonoscopy (ICS). Plain X-ray was used only to check whether patency capsule (PC) was still in the body or had been excreted already without notice.

Close modal

Outcome

The GI patency was confirmed in 53 out of 54 patients (98.5%). The patient who did not confirm GI patency had history of partial resection of the small intestine and ileocecal resection. Plain X-ray showed the PC seemed to be located in oral side of the ileocolic anastomosis (Fig. 4a). In this case, the PC could not be detected by ICS because endoscopic observation of the oral side of the anastomosis was limited despite there was no stenosis (Fig. 4b). There was a patient who did not receive SBCE even GI patency was confirmed by plain X-ray. We did not pursue the exam because the patient was found ileal stenosis by ICS (Fig. 4c). Finally, 52 patients were performed SBCE. As our patients were clinically quiescent to mild active CD, the median Lewis score was 0 (IQR 0, 450, online suppl. Fig. 1; for all online suppl. material, see https://doi.org/10.1159/000539682).

Fig. 4.

The two our cases unable to pursue SBCE in PICS method. a The patient who was not confirmed gastrointestinal patency. Patency capsule (PC) was thought to be at ileocolic anastomotic area. b The PC could not be detected by ileocolonoscopy. c The other patient confirmed gastrointestinal patency, as the PC was absent in plain X-ray 30 h of PC ingestion. Subsequent ICS demonstrated ileal stenosis with ulcerations.

Fig. 4.

The two our cases unable to pursue SBCE in PICS method. a The patient who was not confirmed gastrointestinal patency. Patency capsule (PC) was thought to be at ileocolic anastomotic area. b The PC could not be detected by ileocolonoscopy. c The other patient confirmed gastrointestinal patency, as the PC was absent in plain X-ray 30 h of PC ingestion. Subsequent ICS demonstrated ileal stenosis with ulcerations.

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Safety

Neither PC impaction nor obstructive symptoms were occurred in the cases of PICS method. There were no complications associated with the bowel preparation by PEG and SBCE-related problems such as SBCE retention found during the study period. No other complications that were not directly related to the exam were also documented.

Prevalence of CD has been increasing worldwide similar to that in ulcerative colitis. In Japan, most CD patients have been seen by IBD specialists in specialized referral hospitals, even many of them do not require advanced therapies. Recent increase of the number of CD patients prompted us to think that there are latent needs of care for CD patients in the small-sized facilities. Although there are several kinds of small bowel examinations such as MRE, DAE, IUS, SBCE, and SBFT, a lack of easily applicable standard method is one of the reasons for those small-sized facilities being kept away from management of CD patients, especially with small bowel involvement. For instances, MRE, DAE, and SBFT need large equipment, and SBFT, IUS, and DAE require special skills to perform. SBCE can be performed in small facilities because it only requires a couple of small equipment. In addition, it provides direct images of small lesions with high reproducibility and easy to perform by medical providers with relatively minimal time and effort. However, capsule retention is one of the few complications of SBCE and the rate of it has been thought to be higher in CD patients than other small bowel diseases [10, 11]. In Japan, PC testing is generally performed prior to SBCE in CD patients [19, 20]. In the present study, we presented the safety and the feasibility of a newly developed method that localize PC by ICS in patients with CD.

There are currently some difficulties in PC testing, which could have been the reason for avoiding SBCE use. For example, evaluating the location of PC by plain X-ray is often difficult and may be associated with a risk of misdiagnosis [17]. CT scanning is needed for actual evaluation of PC location in such cases; however, taking CT loses the benefits of SBCE and needs much time and costs. Furthermore, CT scanning is not always enough to determine the PC location, as previously being reported [21]. Therefore, we think that current PC testing method is not perfect, and the development of an easier and more accurate method of PC testing will facilitate the use of SBCE in CD patients.

It has been said that accrual diagnosis of GI patency is most important in the safety use of SBCE [14]. Based on our findings, we expect that PICS method will provide accurate diagnosis of GI patency by an easy localization of PC without additional confirmation with CT scanning. In general, assessment of disease activities in the colon is required as much as that in the small bowel in patients with CD. Therefore, evaluation of disease activity at the same time as PC testing would be very reasonable in clinical management of CD patients. Avoidance of radiation exposure is an additional benefit for those patients receiving CT-free PICS method.

A recent Japanese multicenter study has reported that the small bowel obstruction induced by the tag-less PC impaction could be occurred in 0.89% cases [22]. Although the PC-related bowel obstruction has been identified as a rare adverse event, it might be worsened by adding bowel prep by PEG in patients with subclinical cases with PC-related bowel obstruction. Although there were no adverse events found during the PICS method in clinically quiescent or mild active CD patients in this study, our patient cohort might not represent general CD populations. Nevertheless, the PICS method can be reasonably used in the small-sized facilities managing CD patients without known stenosis. This study has some other limitations such as single-center analysis with relatively small sample size. The rate of PC excretion after 30 h was higher than previous reports [14]. The reason of this is unclear, but the usage of laxatives might stimulate bowel movement. There are many other factors that may affect the timing of PC excretion such as the environmental difference between home and hospital ward. After taking these limitations into consideration, our study at least provides a rationale of the usefulness of PICS method in the early stages of CD patients.

Determining PC location by subsequent ICS is easy, simple, and accurate. We can examine the small and the large intestine in CD patients with our PICS method in just one preparation. Our PICS method makes CT scanning unnecessary to confirm the location of PC. It helps many physicians to manage CD patients even in the small-sized facilities.

This study protocol was reviewed and approved by the Institutional Review Board of Tokyo Yamate Medical Center, Approval No. J-146. Opt-out informed consent protocol was used for use of participant data for research purposes. This consent procedure was reviewed and approved by the Institutional Review Board of Tokyo Yamate Medical Center, Approval No. J-146, date of decision: June 28, 2022.

There are no financial and other conflicts of interest to disclose.

This study has received no financial support.

Guarantor of article: A.S. Specific author contributions: concept, design, and critical reviews – A.S., K.M., and M.F.; materials – A.S, S.O., S.S., and M.F.; data collection and processing, analysis and interpretation, literature search, and writing – A.S. and M.F.; provided and cared for study patients – A.S., S.O., T.N., D.Y., Yo.H., T.T., Y.S., Yu.H., H.S., S.S., M.T., S.I., M.S., and M.F.

The data that support the findings of this study are not publicly available due to their containing information that could compromise the privacy of research participants but are available from the corresponding author (M.F.) upon reasonable request.

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