Prophylactic Endoscopic Clipping of Diverticula (PECoD) (PECoD)

A Prospective Randomised Placebo Controlled Trial on Prophylactic Endoscopic Clipping of Colonic Diverticula (PECoD)

This study will evaluate the effect of endoscopic clipping of colonic diverticula in treatment of symptoms related to diverticular disease. Half of the participants will undergo colonoscopy without the clipping procedure and half will have colonoscopy with clipping of all visible diverticula.

Study Overview

• Status: Completed
• Conditions: Diverticular Disease
• Intervention / Treatment: Procedure: Endoscopic clipping; Other: Placebo - colonoscopy without clipping

Detailed Description

Colonic diverticular disease (DD) is characterised by the presence of sac-like protrusions (diverticula), which form through defects in the muscle layer of the colon wall. It is prevalent in western countries, affecting approximately 70% of individuals by the age of 80. The risk of acquiring diverticular disease increases uniformly with age, with approximately 40% of people aged over 60 years affected in western countries. Diverticular complications may be severe and include pain, inflammation, infection and bleeding. Although the majority of people with diverticular disease are asymptomatic, approximately 25% will experience an episode of acute diverticulitis (the principal inflammatory complication of diverticulosis); of these, 15% will develop other significant and often serious complications such as abscess, fistula or perforation.

King's College Hospital operates a tertiary referral service for patients with diverticular disease that integrates a gastroenterological and colorectal surgical approach to treatment. The investigators increasingly find that many patients have characteristic DD pain and IBS like symptoms with or without a clearly defined episode of diverticulitis. The link between symptomatic diverticular disease and Irritable Bowel Symptoms is reflected to some extent in the literature, however, it remains a matter of significant controversy. Nevertheless, these symptoms are often difficult to control and can be debilitating. Current treatment options for the IBS like symptoms in symptomatic uncomplicated DD are limited. In this age group, a low FODMAP diet, the mainstay treatment for IBS, is impractical and there are few if any controlled studies that address these issues. There is hence a need for alternative therapeutic options. Secondly, complications related to DD are associated with significant morbidity and mortality and comes at significant cost to the health service. At present there is no proven prophylactic intervention to prevent the complications.

The investigators have recently published the results of a feasibility study carried out at King's College Hospital, which assessed the effectiveness of elective endoscopic clipping of diverticula in patients with a history of significant diverticular bleeding. Here, all visible diverticula were closed endoscopically using 'Instinct' endoclips. A diverticula closure rate of 87.2% (129/148) was demonstrated at follow up colonoscopy. In this group, there were no post-procedural complications and no diverticula-associated symptoms reported up to the follow-up colonoscopy. Notably, incidental complete resolution of chronic left sided abdominal pain was noted in one of our subjects.

The investigators now propose the use of elective diverticular clipping in patients with symptomatic diverticulosis with a view to alter the natural history of the disease i.e. to prevent complications of the disease. At the same time the investigators wish to assess their symptomatic response. Patients with symptomatic diverticular disease will be eligible. The trial will be carried out at King's College Hospital endoscopy suite, a tertiary referral centre for endoscopic procedures. The study will include 84 patients. Each patient will be in the study for a period of 12 months.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed symptomatic diverticular disease (5 or more diverticula)
• Age range 18-90 years
• Retains capacity and medically fit for colonoscopy

Exclusion Criteria:

• Does not meet inclusion criteria
• Unable to give informed consent
• Patients with severe co-morbidities and substance misuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; All visible diverticula clipped during index colonoscopy	Procedure: Endoscopic clipping; Endoscopic clips fired to close mucosa over diverticular defects.
Placebo Comparator: Control Group; 5 clips fired at random into colon lumen. No diverticula closed.	Other: Placebo - colonoscopy without clipping; Colonoscopy performed, no clipping of diverticula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of diverticula closure	Number of diverticula pre and post clipping	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in abdominal symptoms	Changes in abdominal symptoms as assessed by the Irritable Bowel Syndrome Symptom Severity Score before and at 3, 6 and 12 months	12 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: 253898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No