Assessing Depth of Small Bowel Insertion at Push Enteroscopy by Using Capsule Endoscopy

NCT05731388 | Unknown

• 1 other identifier: 19-037
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Bleeding from the gastrointestinal tract can originate from the small bowel. Typically, upper and lower endoscopies are unable to identify the site of bleeding and patients need to undergo special endoscopies with longer cameras to examine the small bowel and find the bleeding site. One of the most commonly used scopes to investigate the first part of the small intestinal is called "push enteroscopy". This is an upper endoscopy that uses a pediatric colonoscope, which is longer. To date, it is unknown what percentage of small bowel can be observed with this technique. Hence, this study aimed to determine the extent of small bowel examined by push enteroscopy. Consecutive patients with suspected bleeding from the small intestine will undergo a push enteroscopy and the depth of the examination will be marked with metallic clips. Subsequently, patients will have a capsule endoscopy, which is a little camera that will take multiple pictures of the whole small intestine. The percentage of small bowel that the push enteroscopy examined will be determined by the percentage of small bowel corresponding to the location of the clips visualized on capsule endoscopy.

Conditions

Obscure Gastrointestinal Bleeding; Gastrointestinal Diseases; Gastrointestinal Bleed; Angiodysplasia Intestine

Outcome Measures

Primary Outcomes (1)

• Percentage of small bowel examination

  Proportion of the small intestine that can be evaluated by using the PE technique.

  through study completion, an average of 3 years

Secondary Outcomes (1)

• Diagnostic yield of CE and PE in identifying the cause of obscure gastrointestinal bleeding, comparison of the detection rates between the two modalities and adverse events related to these procedures

  through study completion, an average of 3 years

Interventions

Push enteroscopy DIAGNOSTIC_TEST

A push enteroscopy using a pediatric colonoscope will be performed along with capsule endoscopy. These are part of the standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients (aged \> 18 years) referred to a single tertiary referral center for investigation of OGIB will be prospectively recruited

You may qualify if:

• Patients with overt signs of GI bleeding (OGIB) (hematochezia or melena with an associated drop in hemoglobin) or occult signs of GI bleeding in the form of persistent or recurrent iron deficiency anemia and had undergone esophagogastroduodenoscopy (EGD) and colonoscopy that were negative for a source of bleeding.

You may not qualify if:

• Significant cardiopulmonary disease, an implanted electromedical device, pregnancy, previous gastrectomy, extensive Crohn's disease with suspicion for stricturing or fistulizing small bowel disease

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (2)

• Barkin JS, Lewis BS, Reiner DK, Waye JD, Goldberg RI, Phillips RS. Diagnostic and therapeutic jejunoscopy with a new, longer enteroscope. Gastrointest Endosc. 1992 Jan-Feb;38(1):55-8. doi: 10.1016/s0016-5107(92)70333-2. No abstract available.

  PMID: 1612382 BACKGROUND

• Cortegoso Valdivia P, Skonieczna-Zydecka K, Pennazio M, Rondonotti E, Marlicz W, Toth E, Koulaouzidis A. Capsule endoscopy transit-related indicators in choosing the insertion route for double-balloon enteroscopy: a systematic review. Endosc Int Open. 2021 Feb;9(2):E163-E170. doi: 10.1055/a-1319-1452. Epub 2021 Jan 25.

  PMID: 33532554 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases; Gastrointestinal Hemorrhage

Interventions

Double-Balloon Enteroscopy

Condition Hierarchy (Ancestors)

Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Christopher Teshima, MD MSc PhD

  Unity Health Toronto, St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: February 16, 2023
• Study Start: July 1, 2019
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Locations

CA (1)