Clinical trial NCT05228379: Small Bowel Capsule Endoscopy: Experience From a Single Large Tertiary Care Centre
Official title: Small Bowel Capsule Endoscopy: Experience From a Single Large Tertiary Care Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Disease
Small Bowel Ulcers
Capsule Endoscopy
Small Bowel Tumor
Keywords: capsule endoscopy
small bowel
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 1157
Sex: ALL
Minimum age (years): 6
Maximum age (years): 87
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes patients who underwent capsule endoscopy from Jan 2013 till 30 June, 2021.

Brief summary: Examination of the small bowel has been considered a challenge for several anatomical (i.e. distance from external orifices, length) and physiological (i.e. active peristalsis) reasons. Conventional techniques of endoscopy are limited by length while radiologic examinations, such as barium studies, are insensitive for evaluating small bowel pathology. An ingestible miniature camera device capable of obtaining images of the whole small intestine was developed due to a need for the exploration of this "final frontier". The purpose of this article is to review and share our institution's results using small bowel capsule endoscopy, with special reference to the existing literature.

Detailed description: 1. INTRODUCTION

   Examination of the small bowel (SB) has been considered a challenge for several anatomical (i.e. distance from external orifices, length) and physiological (i.e. active peristalsis) reasons. Conventional techniques of endoscopy are limited by length while radiologic examinations, such as barium studies, are insensitive for the evaluation of pathology in the SB. An ingestible miniature camera device capable of obtaining images of the whole small intestine was developed due to a need for the exploration of this "final frontier". Video capsule endoscopy (CE) is a breakthrough in medical history for noninvasive imaging of the entire small intestine. It was first introduced in 2000, and since then more than 700 studies have been published, which is indicative of its ease and the widespread acceptance of this new diagnostic tool. A wide range of uses for CE has been reported in the literature, but the majority of the studies have aimed to evaluate the cause of obscure gastrointestinal bleeding (OGIB).
2. RATIONALE The purpose of this article is to review and share our institution's experience using small bowel CE, with special reference to the existing literature. Most published reports on capsule endoscopy are limited to small group of patients.
3. STUDY OBJECTIVES 3A. Primary Objective- To study the indications and diagnostic yield of capsule endoscopy.

3B. Secondary Objective- To study the gastric emptying time, small bowel transit time and findings visualized with capsule endoscopy.

4. STUDY POPULATION This observational retrospective study will be conducted in AIG Hospitals, Hyderabad. All patients who underwent capsule endoscopy till 30 June, 2021 will be enrolled in the study.

5. DESIGN AND DURATION OF THE STUDY- It will be a retrospective observational study.

6. METHODOLOGY

6a. SUBJECT RECRUITMENT - All patients who underwent capsule endoscopy in our hospital till 30 June, 2021 will be enrolled in the study.

6b. RANDOMIZATION AND BLINDING- N/A

6c. STUDY METHODS- This observational study will be conducted after obtaining ethical clearance from institutional human ethical committee. All patients who underwent capsule endoscopy till date will be enrolled in the study.

6d. STUDY PROCEDURE- The data will be entered in Microsoft excel sheet and analysed ' 6e. METHODS OF ASSESSMENT- The following variables will be noted. A. Age of the patient B. Indications of the procedure C. Pre-Existing illness D. Gastric Emptying time E. Small Bowel transit time F. Capsule Retention G. Findings visualized on capsule endoscopy study

6e. STOPPING OR DISCONTINUATION CRITERIA- N/A

7. SAMPLE SIZE CALCULATION- The sample size will include all patients who underwent capsule endosocopy till 30th June 2021 in AIG hospitals Hyderabad.

8. STATISTICAL ANALYSIS- Data will be expressed as median and percentile values (5th, 25th, 75th and 95th percentiles). The upper limit of normal will be defined as the 95th percentile of expected values. P≤0.05 will be considered statistically significant.

9. ETHICAL JUSTIFICATION OF THE STUDY Small Bowel Capsule endoscopy is a safe and effective procedure for diagnosis of small bowel disorders. It is especially helpful in finding the cause for obscure gastro-intestinal bleed. There is lack of large studies on diagnostic yield and other visualized findings. This study aims to share our institution's results using small bowel CE, with special reference to the existing literature.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent capsule endoscopy in AIG Hospitals Hyderbad till 30 June, 2021 will be enrolled in the study.

Exclusion Criteria:

* Patients in whom capsule was unable to reach caecum.

Primary outcomes:
measure: Indications for doing capsule endoscopy procedure
timeFrame: 8-9 years
Secondary outcomes:
measure: Findings visualized on capsule endoscopy.
timeFrame: 8-9 years
measure: Diagnostic yield of capsule endoscopy
timeFrame: 8-9 years
Other outcomes:
Locations:
Study officials:
affiliation: Consultant Gastroenterologist
name: Neeraj Singla, MBBS, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goenka MK, Majumder S, Kumar S, Sethy PK, Goenka U. Single center experience of capsule endoscopy in patients with obscure gastrointestinal bleeding. World J Gastroenterol. 2011 Feb 14;17(6):774-8. doi: 10.3748/wjg.v17.i6.774.
citation: Yung DE, Robertson AR, Davie M, Sidhu R, McAlindon M, Rahman I, Patel P, Sinha L, Mason S, Brzeszczynska J, Douglas S, Plevris JN, Koulaouzidis A. Double-headed small-bowel capsule endoscopy: Real-world experience from a multi-centre British study. Dig Liver Dis. 2021 Apr;53(4):461-466. doi: 10.1016/j.dld.2021.01.017. Epub 2021 Feb 8.
citation: Flemming J, Cameron S. Small bowel capsule endoscopy: Indications, results, and clinical benefit in a University environment. Medicine (Baltimore). 2018 Apr;97(14):e0148. doi: 10.1097/MD.0000000000010148.
citation: Kav T, Bayraktar Y. Five years' experience with capsule endoscopy in a single center. World J Gastroenterol. 2009 Apr 28;15(16):1934-42. doi: 10.3748/wjg.15.1934.