NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome

NCT02570516 | Completed

• 2 other identifiers: P1401082015-A00552-47
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 7

Brief Summary

This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome

Conditions

Lynch Syndrome

Keywords

Indigo carmine chromoendoscopy; Narrow band imaging; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)

  The adenoma detection rate (number of adenoma and/or adenocarcinoma) of NBI and the additional adenoma detection rate of indigo carmine.

  procedure time

Secondary Outcomes (4)

• All neoplastic lesions detected during colonoscopy

  procedure time

• Cost of each procedure (NBI vs Indigo carmine)

  Procedure time

• Duration of each procedure (NBI vs Indigo carmine)

  Procedure time

• Number of subject with adverse events as mesure of safety.

  One month after colonoscopy

Study Arms (2)

Indigo carmine colonoscopy

ACTIVE COMPARATOR

Colonoscopy using indigo carmine is performed in second place

Procedure: Colonoscopy

NBI colonoscopy

EXPERIMENTAL

Colonoscopy using NBI is performed in first place

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.

Indigo carmine colonoscopy; NBI colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lynch Syndrome with an identified mutation in one of the genes MutL Homolog 1 (MLH1), MutL Homolog 2 (MLH2), MutS homolog6 (MSH6), PMS2 or epithelial cellular adhesion molecule (EpCAM)
• Age between 18 and 80
• Indication of a screening colonoscopy

You may not qualify if:

• Any sign of intestinal occlusion contra-indicating bowel preparation
• History of total or subtotal colectomy
• Any serious medical condition contra-indicating colonoscopy under general anesthesia
• Pregnant or breast feeding women
• Any coagulation disorder contra-indicating biopsies or endoscopic resections
• Any history of hypersensitivity to indigo carmine
• Adults subject to a legal protection measure (guardianship or curatorship)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ARC Foundation for Cancer Research: collaborator

Study Sites (7)

HCL - Hôpital Edouard-Herriot

Lyon, Auvergne-Rhône-Alpes, 69003, France

Location

CHRU de Tours - Hôpital Trousseau

Chambray-lès-Tours, Centre-Val de Loire, 37170, France

Location

CHU Nantes - Hôtel-Dieu

Nantes, Pays de la Loire Region, 44093, France

Location

AP-HP - Hôpital Européen Georges-Pompidou

Paris, 75015, France

Location

AP-HP - Hôpital Saint-Antoine

Paris, Île-de-France Region, 75012, France

Location

AP-HP - Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Location

Institut Gustave-Roussy

Villejuif, Île-de-France Region, 94805, France

Location

Related Publications (1)

• Cellier C, Perrod G, Colas C, Dhooge M, Saurin JC, Lecomte T, Coron E, Rahmi G, Savale C, Chaussade S, Bellanger J, Dray X, Benech N, Le Rhun M, Barbieux JP, Pereira H, Chatellier G, Samaha E. Back-to-Back Comparison of Colonoscopy With Virtual Chromoendoscopy Using a Third-Generation Narrow-Band Imaging System to Chromoendoscopy With Indigo Carmine in Patients With Lynch Syndrome. Am J Gastroenterol. 2019 Oct;114(10):1665-1670. doi: 10.14309/ajg.0000000000000386.

  PMID: 31498154 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

• CHRISTOPHE CELLIER, MD, PHD

  Hopital europeen Georges Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 7, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

FR (7)