ClinicalTrials.gg
CompletedNCT03935100PECoDUpdated Mar 20, 2023

Prophylactic Endoscopic Clipping of Diverticula (PECoD)

An interventional study of Endoscopic clipping and Placebo - colonoscopy without clipping in Diverticular Disease, sponsored by King's College Hospital NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diverticular Disease

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03

In context

Diverticular Diseases

44 studies on the registry are indexed under Diverticular Diseases; 9 are open to participants now.

This study's enrollment of 84 is close to the median of 81 across 31 interventional studies indexed under Diverticular Diseases.

Browse Diverticular Diseases studies →

Lead sponsor

King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Does not meet inclusion criteria
  • Unable to give
  • Patients with severe co-morbidities and substance misuse
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Treatment Group

    All visible diverticula clipped during index colonoscopy

    Procedure: Endoscopic clipping

  • Placebo comparator
    Control Group

    5 clips fired at random into colon lumen. No diverticula closed.

    Other: Placebo - colonoscopy without clipping

Interventions

  • ProcedureEndoscopic clipping

    Endoscopic clips fired to close mucosa over diverticular defects.

  • OtherPlacebo - colonoscopy without clipping

    Colonoscopy performed, no clipping of diverticula

06

What researchers measure

Primary outcomes

  1. Rate of diverticula closure

    Number of diverticula pre and post clipping

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 12 months

07

Study locations

1 site
  • King's College Hospital
    London, SE5 9RS, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in Mar 2023, 42 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2019
First posted
May 2, 2019
StartActual
Sep 1, 2019
Primary completionActual
Mar 1, 2023
CompletionActual
Mar 16, 2023
Last update
Mar 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03935100
Responsible party
Sponsor
First posted
May 2, 2019
Start date
Sep 1, 2019
Primary completion
Mar 1, 2023
Completion
Mar 16, 2023
Last update
Mar 20, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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