Evaluation of the Diagnostic Role of Enteroscopy in Small Intestinal Diseases at Al-Rajhi University Hospital

NCT05470946 | Unknown

• 1 other identifier: Diagnostic role of enteroscopy
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To identify the role of enteroscopy in diagnosis and treatment of small intestinal diseases.

Conditions

Small Intestine Disease

Outcome Measures

Primary Outcomes (1)

• Diagnostic role of enteroscopy in small intestinal diseases

  To assess frequency of benign and malignant lesions of small intestine by histopathpathological examination of the obtained biopsy

  2 years

Secondary Outcomes (1)

• Side effects and complications of enteroscopy

  2 years

Study Arms (1)

Enteroscopy

OTHER

Double balloon enteroscopy

Device: Double balloon enteroscopy

Interventions

Double balloon enteroscopy DEVICE

Double balloon enteroscopy (EN-580T, Fujifilm, Japan)

Enteroscopy

Eligibility Criteria

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

You may qualify if:

• All patients will undergo gastroscopy, colonoscopy, abdominal computed tomography and/or magnetic resonance imaging, or radionuclide examination without a clear diagnosis will be subjected to enteroscopy including:
• patients with obscure digestive tract bleeding
• patients with obscure diarrhea
• patients with obscure abdominal pain
• patients with obscure weight loss
• patients with obscure intestinal obstruction • Patients with imaging suggesting small intestinal lesions

You may not qualify if:

• Patients who aren't eligible for anesthesia e.g.: severe cardiovascular, respiratory dysfunction or coagulopathy.
• Patients who aren't eligible for endoscopy e.g.: fulminant colitis, acute perforation and peritonitis, and impending perforation, intestinal obstruction, recent intestinal surgery.
• Patient's refusal

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Baggus EMR, Hadjivassiliou M, Cross S, Penny H, Urwin H, Watson S, Woodward JM, Sanders DS. How to manage adult coeliac disease: perspective from the NHS England Rare Diseases Collaborative Network for Non-Responsive and Refractory Coeliac Disease. Frontline Gastroenterol. 2019 Aug 8;11(3):235-242. doi: 10.1136/flgastro-2019-101191. eCollection 2020.

  PMID: 32419915 BACKGROUND

• Genta RM, Sonnenberg A. The yield of colonic biopsy in the evaluation of chronic unexplained diarrhea. Eur J Gastroenterol Hepatol. 2015 Aug;27(8):963-7. doi: 10.1097/MEG.0000000000000365.

  PMID: 26114907 BACKGROUND

• Ghoshal UC, Gwee KA. Post-infectious IBS, tropical sprue and small intestinal bacterial overgrowth: the missing link. Nat Rev Gastroenterol Hepatol. 2017 Jul;14(7):435-441. doi: 10.1038/nrgastro.2017.37. Epub 2017 May 17.

  PMID: 28513629 BACKGROUND

• ASGE Standards of Practice Committee; Gurudu SR, Bruining DH, Acosta RD, Eloubeidi MA, Faulx AL, Khashab MA, Kothari S, Lightdale JR, Muthusamy VR, Yang J, DeWitt JM. The role of endoscopy in the management of suspected small-bowel bleeding. Gastrointest Endosc. 2017 Jan;85(1):22-31. doi: 10.1016/j.gie.2016.06.013. Epub 2016 Jun 30. No abstract available.

  PMID: 27374798 BACKGROUND

• Kamboj AK, Oxentenko AS. Clinical and Histologic Mimickers of Celiac Disease. Clin Transl Gastroenterol. 2017 Aug 17;8(8):e114. doi: 10.1038/ctg.2017.41.

  PMID: 28817113 BACKGROUND

• Makkar R, Lopez R, Shen B. Clinical utility of retrograde terminal ileum intubation in the evaluation of chronic non-bloody diarrhea. J Dig Dis. 2013 Oct;14(10):536-42. doi: 10.1111/1751-2980.12082.

  PMID: 23777610 BACKGROUND

• Kinoshita Y, Ariyoshi R, Fujigaki S, Tanaka K, Morikawa T, Sanuki T. Endoscopic diagnosis of chronic diarrhea. DEN Open. 2021 Sep 28;2(1):e53. doi: 10.1002/deo2.53. eCollection 2022 Apr.

  PMID: 35310743 BACKGROUND

• Mizumoto N, Sasaki Y, Abe Y, Yagi M, Kon T, Onozato Y, Sakai T, Ito M, Umehara M, Ueno Y. Small-bowel Capsule Endoscopic Features in Patients with Eosinophilic Gastroenteritis: Three Case Reports. Intern Med. 2021 Sep 15;60(18):2961-2965. doi: 10.2169/internalmedicine.6935-20. Epub 2021 Mar 29.

  PMID: 33776012 BACKGROUND

• Nakano M, Oka S, Tanaka S, Igawa A, Kunihara S, Ueno Y, Ito M, Chayama K. Indications for Small-bowel Capsule Endoscopy in Patients with Chronic Abdominal Pain. Intern Med. 2017;56(12):1453-1457. doi: 10.2169/internalmedicine.56.7458. Epub 2017 Jun 15.

  PMID: 28626168 BACKGROUND

• Rowinski SA, Christensen E. Epidemiologic and therapeutic aspects of refractory coeliac disease - a systematic review. Dan Med J. 2016 Dec;63(12):A5307.

  PMID: 27910801 BACKGROUND

• Shin JY, Park IS, Bang BW, Kim HK, Shin YW, Kwon KS. A Case of Primary Small Bowel Melanoma Diagnosed by Single-Balloon Enteroscopy. Clin Endosc. 2017 Jul;50(4):395-399. doi: 10.5946/ce.2016.153. Epub 2017 Jun 2.

  PMID: 28783927 BACKGROUND

• Takenaka K, Ohtsuka K, Kitazume Y, Matsuoka K, Fujii T, Nagahori M, Kimura M, Fujioka T, Araki A, Watanabe M. Magnetic resonance evaluation for small bowel strictures in Crohn's disease: comparison with balloon enteroscopy. J Gastroenterol. 2017 Aug;52(8):879-888. doi: 10.1007/s00535-016-1284-z. Epub 2016 Nov 15.

  PMID: 27848026 BACKGROUND

• Tang L, Huang LY, Cui J, Wu CR. Effect of Double-Balloon Enteroscopy on Diagnosis and Treatment of Small-Bowel Diseases. Chin Med J (Engl). 2018 Jun 5;131(11):1321-1326. doi: 10.4103/0366-6999.232802.

  PMID: 29786046 BACKGROUND

MeSH Terms

Interventions

Double-Balloon Enteroscopy

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

Central Study Contacts

Maiada Ibrahim

CONTACT

01068388643; maiada145@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 22, 2022
• Study Start: August 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 22, 2022

Record last verified: 2022-07