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Prophylactic Endoscopic Clipping of Diverticula (PECoD) (PECoD)

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ClinicalTrials.gov Identifier: NCT03935100
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diverticular Disease Procedure: Endoscopic clipping Other: Placebo - colonoscopy without clipping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Blinded to clipping, undergo same procedure
Primary Purpose: Treatment
Official Title: A Prospective Randomised Placebo Controlled Trial on Prophylactic Endoscopic Clipping of Colonic Diverticula (PECoD)
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of diverticula closure [ Time Frame: 12 months ]
    Number of diverticula pre and post clipping


Secondary Outcome Measures :
  1. Changes in abdominal symptoms [ Time Frame: 12 months ]
    Changes in abdominal symptoms as assessed by the Irritable Bowel Syndrome Symptom Severity Score before and at 3, 6 and 12 months



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935100


Locations
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United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Sophie Williams    02032998773    sophie.williams15@nhs.net   
Contact: Simbisai Ratcliff    02032998773    simbisai.ratcliff@nhs.net   
Sponsors and Collaborators
King's College Hospital NHS Trust
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT03935100    
Other Study ID Numbers: 253898
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulum
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical