Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas

Colorectal Cancer Clinical Trial

— ENDOCOLES  

Official title:

Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436004
• Other study ID #: ENDOCOLES
• Status: Completed
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: June 4, 2019

Study information

• Verified date: August 2019
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study

Description:

Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy.

Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1453
• Est. completion date: June 4, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients must be adults (=18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria:

1. Patients with positive immunologic fecal occult blood test (IFOBT) for population screening.

2. Patients invited to an opportunistic screening colonoscopy or included regional population screening program.

3. Patients with a family history of CRC and indication of screening colonoscopy.

4. Patients with follow-up colonoscopy indication by personal history of adenomas.

Exclusion Criteria:

1. Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc).

2. Symptomatic patients with indication of diagnostic colonoscopy.

3. Patients with a personal history of CRC.

4. Patients with a personal history of chronic inflammatory bowel disease (IBD).

5. Patients with a known personal history of hereditary CRC syndrome:

I. No polyposis (Lynch syndrome). II. Polypic.

6. Patients with suspected attenuated polyposis (> 20 adenomas) with genetic diagnosis not defined.

7. Patients with total or partial colic resection.

8. Complete colonoscopy with an adequate preparation (total Boston =6 with at least score =2 per segment) in a period of less than a year

9. Pregnant or breastfeeding mothers.

10. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent.

11. Patients with any serious and uncontrolled medical, psychological, psychiatric, geographic or social problem that could interfere with the participation of the patient in the study or not allow an adequate follow-up and adherence with the protocol and evaluation of the results of the study.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colorectal Cancer

Intervention

Device:
• Colonoscopy
Patients undergoing screening colonoscopy
• Colonoscopy with specific device (Endocuff Vision)
Patients undergoing screening colonoscopy using the Endocuff Vision device

Locations

Country	Name	City	State
Spain	Department of Gastroenterology, Hospital Clínico San Carlos	Madrid
Spain	Department of Gastroenterology, Hospital General Universitario Gregorio Marañón	Madrid
Spain	Department of Gastroenterology, Hospital Universitario 12 de Octubre	Madrid
Spain	Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon	Madrid
Spain	Department of Gastroenterology, Hospital Universitario La Paz	Madrid
Spain	Department of Gastroenterology, Hospital Universitario La Princesa	Madrid
Spain	Department of Gastroenterology, Hospital Universitario Ramón y Cajal	Madrid
Spain	Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Alberto Herreros de Tejada Echanojáuregui	Spanish Clinical Research Network - CAIBER

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate (ADR)	Number of adenoma detected by colonoscopy	1 day
Primary	Mean adenoma per procedure (MAP)	Mean of adenoma detected by patient	1 day
Secondary	Total number of adenomas detected by colonoscopy		1 day
Secondary	Total number of advanced adenomas detected by colonoscopy		1 day
Secondary	Total number of serrated lesions with or without detected dysplasia by colonoscopy		1 day