Capsule endoscopy (CE) enables imaging of the gastrointestinal tract by transferring images wirelessly from a capsule endoscope to a data recorder through a sensing system. The introduction of CE provided a significant advancement in the diagnosis and management of small bowel diseases. The current diagnostic yields of CE in prior studies were 35% to 77% in patients with obscure gastrointestinal bleeding (OGIB) [
CE can bypass about 30% of separate lesions, particularly in the proximal small bowel [
Increasing the diagnostic yield of CE prior to specific interventions may have a far better impact on the treatment course [
This is the first clinical study to use two CEs simultaneously. In this pilot study, we performed simultaneous application of the two capsule endoscopes and evaluated the detection rate of duodenal papilla and diagnostic yield.
Patients indicated for CE, including those with OGIB, chronic diarrhea, and chronic abdominal pain, were included in the trial. All patients were between 20–80 years old. Patients suspected of having small bowel stenosis, swallowing difficulties, severe advanced respiratory disease, or cardiovascular or neuropsychiatric disease were excluded. Pregnant patients and those with implantable electronic devices were also excluded. All patients underwent esophagogastroduodenoscopy (EGD) and colonoscopy before the dual CE examination.
This study protocol adhered to the principles of the Declaration of Helsinki and was reviewed and approved ethically by the institutional review board of the Korea University Anam Hospital (Permit Number: ED16199). All patients provided a written informed consent at the time of enrollment.
The patients underwent fasting for 8 hours and completed bowel cleansing with 2 L of polyethylene glycol solution with ascorbic acid (Coolprep; TaeJoon Pharmaceuticals, Seoul, Korea) 2 hours prior to the examination [
Examinations of the CE procedures were performed according to previously published guidelines [
Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp., Armonk, NY, USA). Completion rates and detection rates of the dual CE were analyzed using the McNemar test. Reading times of the two capsule endoscopes were compared using the Wilcoxon signed-rank test. The kappa value was used to evaluate the agreement between PillCam SB3 and MiroCam. In all tests,
A total of 20 consecutive patients who underwent dual CE procedures were enrolled in the study. Among these patients, 12 (60%) were male and 8 (40%) were female; the mean age of the patients was 59.8 ± 14.4 (range 33–78) years. The indications for CE were as follows: OGIB in 15 patients (75%) and chronic abdominal pain or diarrhea in 5 patients (25%) (Table
Characteristics of patients and technical information on MiroCam and PillCam SB3 capsule endoscopes.
Number | Age | Sex | Indication | Total operating time of CE | Completion to the cecum | Significant findings or diagnosis on CE | |||
---|---|---|---|---|---|---|---|---|---|
MiroCam | PillCam SB3 | MiroCam | PillCam SB3 | MiroCam | PillCam SB3 | ||||
1 | 59 | M | Chr.Abd.pain | 12:00:04 | 14:17:47 | 1 | 1 | 0 | 0 |
2 | 50 | M | OGIB | 07:30:42 | 14:50:20 | 1 | 1 | Polyp | Polyp, erosion |
3 | 66 | F | OGIB | 12:00:02 | 15:10:33 | 1 | 1 | 0 | Ulcer, erosion |
4 | 74 | M | Chr.Abd.pain | 11:57:22 | 14:43:57 | 1 | 1 | 0 | 0 |
5 | 67 | F | OGIB | 12:00:14 | 12:46:07 | 1 | 1 | 0 | 0 |
6 | 54 | M | OGIB | 12:00:26 | 15:34:43 | 1 | 1 | Angiodysplasia | Angiodysplasia |
7 | 63 | M | OGIB | 12:00:24 | 15:40:37 | 1 | 1 | Angiodysplasia, polyp | Polyp |
8 | 34 | M | Chr.Abd.pain | 12:00:14 | 15:12:39 | 1 | 1 | 0 | 0 |
9 | 61 | F | OGIB | 12:00:15 | 14:55:28 | 1 | 1 | Angiodysplasia | 0 |
10 | 64 | M | OGIB | 12:00:33 | 06:42:56 | 1 | 1 | Angiodysplasia | 0 |
11 | 50 | F | OGIB | 07:47:42 | 10:24:30 | 1 | 1 | Polyp, erosion | Polyp, erosion |
12 | 78 | F | Chr.Abd.pain | 12:00:03 | 15:07:23 | 1 | 1 | 0 | 0 |
13 | 56 | M | Chr.Abd.pain | 12:00:25 | 14:54:17 | 1 | 1 | 0 | 0 |
14 | 73 | M | OGIB | 12:00:22 | 12:11:14 | 1 | 1 | Angiodysplasia | Angiodysplasia |
15 | 73 | M | OGIB | 12:00:00 | 14:33:12 | 1 | 1 | Angiodysplasia, ulcer | Ulcer, erosion |
16 | 69 | F | OGIB | 12:00:00 | 13:26:19 | 1 | 1 | Angiodysplasia, diverticulum | Erosion |
17 | 71 | F | OGIB | 12:00:00 | 13:16:18 | 1 | 1 | 0 | Angiodysplasia, erosion |
18 | 33 | M | OGIB | 12:00:02 | 14:15:00 | 0 | 1 | Angiodysplasia, erosion | 0 |
19 | 65 | F | OGIB | 12:00:11 | 14:52:29 | 1 | 1 | 0 | Ulcer scar, erosion |
20 | 52 | M | OGIB | 12:00:05 | 14:53:12 | 1 | 1 | Erosion | Angiodysplasia, erosion |
Chr.Abd.pain: chronic abdominal pain; OGIB: obscure gastrointestinal bleeding.
The duodenal papilla was identified in 9 (45%) patients with PillCam SB3 alone and 10 (50%) patients with MiroCam alone (Table
Duodenal papilla detection via the MiroCam and PillCam SB3 capsule endoscopes.
MiroCam | PillCam SB3 | |
---|---|---|
Patient 1 | ||
Patient 2 | ||
Patient 3 | ||
Patient 4 | ||
Patient 5 | ||
Patient 6 | ||
Patient 7 | ||
Patient 8 | ||
Patient 9 | ||
Patient 10 | ||
Patient 11 | ||
Patient 12 | ||
Patient 13 | ||
Patient 14 | ||
Patient 15 | ||
Patient 16 | ||
Patient 17 | ||
Patient 18 | ||
Patient 19 | ||
Patient 20 |
Comparison of duodenal papilla detection rates.
Authors | Capsule | Study population ( |
Recording speed (frames/s) | Duodenal papilla detection (%) |
---|---|---|---|---|
Kong et al. [ |
M2A, Given Imaging | 110 | 15 | 43.6 |
Clarke et al. [ |
SB1, Given Imaging | 125 | 5 | 10.4 |
Nakamura et al. [ |
SB1, Given Imaging | 96 | 10 | 18 |
Selby and Prakoso [ |
SB2, Given Imaging | 50 | n/s | 18 |
Monteiro et al. [ |
SB3, Given Imaging | 75 | n/s | 42.7 |
Agreement between the MiroCam and PillCam SB3 results.
PillCam SB | ||||
---|---|---|---|---|
Negative | Significant abnormal | Total | ||
MiroCam | Negative | 6 | 3 | 9 |
Significant abnormal | 3 | 8 | 11 | |
Total | 9 | 11 | 20 |
In the examples of concordant cases, MiroCam and PillCam SB3 revealed polypoid masses in the distal ileum of the same patients (Figure
Examples of concordant cases. The MiroCam and PillCam SB3 revealed a polypoid mass in the proximal jejunum (a and b) of patient 2 and a polypoid mass in the distal ileum (c and d) of patient 7.
Examples of discordant cases. In patient 5, PillCam SB3 revealed a polypoid mass in the distal ileum (a), while MiroCam was not able to capture the lesion (b). In patient 6, the PillCam SB3 detected angiodysplasia in the jejunum (c), while the MiroCam could not (d).
The mean reading time of the two devices were 26.3 ± 5.4 minutes for PillCam SB3 and 30.1 ± 5.5 minutes for the MiroCam (
Comparison of reading times (MiroCam versus PillCam SB3 examination).
This prospective study demonstrated that dual CE is a safe and efficient tool for small bowel examination. To assess the ability of dual CE, we defined the duodenal papilla as the only landmark in the small bowel. As a result, the duodenal papilla was detected in more than 70% of the patients. To the best of our knowledge, this is the first clinical trial of simultaneous dual CE application. Previously, the concepts of repeat CE have been described. Although these methods offer additional findings compared to prior CE examination in patients with OGIB, they had disadvantages such as additional medical costs and being time-consuming [
We need to focus on the possible cost-effectiveness of dual CE exam in terms of total medical expenditure and patients’ preferences. Although push enteroscopy and device-assisted enteroscopy (DAE), such as balloon-assisted enteroscopy, can directly evaluate the pathological lesions and perform procedures such as bleeding control or tissue sampling, their invasive nature hinders them from being conveniently performed as a first approach. Furthermore, current guidelines usually recommend DAE or push enteroscopy to be done as additional management for positive findings of CE [
Although previous studies only compared the diagnostic yield of repeat CE, we also measured the detection rate of the duodenal papilla. There are no reliable criteria for CE examination; therefore, it is difficult to evaluate the actual diagnostic yield and sensitivity of CE. Additionally, the actual lesion visualized using CE does not necessarily coincide with the clinical outcome in many cases.
Dual CE exam did not increase unfavorable events, such as CE retention or small bowel obstruction. Prior to the application of dual CE, we need to exclude the potentially high-risk patients, such as patients with postoperative adhesions, with the use of abdominal CT scan or upper gastrointestinal series. Normally, dual CE could be performed safely in patients without complications or contraindications.
Our study has a few limitations. Because of its observational design, the number of enrolled patients was small for a pilot study, and furthermore no outcome data was presented, which might be altered after the dual CE procedure. However, a prospective study using both MiroCam and PillCam SB3 has not been previously conducted; therefore, we attempted to evaluate dual CE examination using these two capsules as they are readily available in Korea. Other capsule endoscopes such as the EndoCapsule (Olympus Medical Systems Corp., Tokyo, Japan) or OMOM capsule (Jinshan Science and Technology Co. Ltd., Chongqing, China) will require their own evaluation as part of a dual CE (e.g., MiroCam + EndoCapsule, MiroCam + OMOM capsule, or PillCam SB3 + OMOM capsule), given the variability of the availability of these devices in different countries.
This study demonstrated that dual CE is a safe and efficient tool for small bowel examination. Dual CE substantially increased the detection rate of duodenal papilla up to 75%, without significant adverse events. To clarify this result, further extensive research using dual CE is necessary. The occurrence of severe adverse events and significant interference of electrical transmission should be defined along with a large clinical trial. Additionally, alterations in treatment sequence or overall patient outcome after dual CE examinations should be investigated.
In conclusion, dual CE has a higher diagnostic accuracy than single CE. Dual CE could increase the diagnostic power of existing CE systems with the use of simply applicable methods.
The abstract of this study was presented at the conference of the Korean Society of Gastrointestinal Endoscopy.
The authors declare that they have no conflicts of interest.
Seung Han Kim and Hyuk Soon Choi contributed equally to this work.
This study was supported by the Ministry of Trade, Industry & Energy (MOTIE, Korea) under the Industrial Technology Innovation Program no. 10060251, “Development of diagnostic device for functional dyspepsia based on Korean-Western medicine fusion abdominal diagnosis,” and by IntroMedic Co. Ltd., Seoul, Korea.