High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome.

NCT02951390 | Completed

• 1 other identifier: HCB/2016/0440
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection rate in patients with Lynch syndrome.

Conditions

Lynch Syndrome

Keywords

Surveillance; Colorectal cancer; Colonoscopy; Adenoma; Chromoendoscopy

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  Adenoma detection rate is defined as the proportion of patients with at least one adenoma in each arm

  one year

Secondary Outcomes (7)

• Mean of adenomas per patient

  one year

• Mean number per patient of total polyps

  one year

• Mean number per patient of total serrated lesions

  one year

• Polyp detection rate

  one year

• Serrated lesions detection rate

  one year

Study Arms (2)

High-definition white-light endoscopy

ACTIVE COMPARATOR

High-definition white-light endoscopy without indigo carmine instilation

Other: High-definition white-light endoscopy

High-definition chromoendoscopy

NO INTERVENTION

High-definition indigo-carmine chromoendoscopy

Interventions

High-definition white-light endoscopy OTHER

The intervention is do not perform chromoendoscopy

High-definition white-light endoscopy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with proven pathologic germline mutation in one of the mismatch-repair (MMR) gene (MLH1, MSH2, MSH6, PMS2 or Epcam) who will undergo surveillance colonoscopy

You may not qualify if:

• Patients with total colectomy
• Concomitant inflammatory bowel disease
• Inadequate bowel preparation (Boston scale \<2 in any colonic segment)
• Incomplete procedure (without intubation of cecum or ileo-colonic anastomosis)
• Previous colonoscopy in less than one year
• Inability to sign informed consent

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Study Sites (1)

María Pellisé. MD. PhD.

Barcelona, 08036, Spain

Location

Related Publications (21)

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• Rivero-Sanchez L, Arnau-Collell C, Herrero J, Remedios D, Cubiella J, Garcia-Cougil M, Alvarez V, Albeniz E, Calvo P, Gordillo J, Puig I, Lopez-Vicente J, Huerta A, Lopez-Ceron M, Salces I, Penas B, Parejo S, Rodriguez de Santiago E, Herraiz M, Carretero C, Gimeno-Garcia AZ, Saperas E, Alvarez-Urturi C, Moreira R, Rodriguez de Miguel C, Ocana T, Moreira L, Carballal S, Sanchez A, Jung G, Castells A, Llach J, Balaguer F, Pellise M; EndoCAR group from Spanish Gastroenterology Association (AEG) and Spanish Society of Digestive Endoscopy (SEED). White-Light Endoscopy Is Adequate for Lynch Syndrome Surveillance in a Randomized and Noninferiority Study. Gastroenterology. 2020 Mar;158(4):895-904.e1. doi: 10.1053/j.gastro.2019.09.003. Epub 2019 Sep 12.

  PMID: 31520613 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Colorectal Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

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; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• María Pellisé, MD. PhD.

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD. Consultant

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2017
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)