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NCT02094456
Prophylactic Elective Clipping of Colonic Diverticula
NA trial testing Endoscopic clipping of diverticula in Diverticular Disease in 9 participants. Completed in 5 May 2018.
1 April 2017
Quick facts
| Lead sponsor | King's College Hospital NHS Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 9 |
| Start date | 1 April 2016 |
| Primary completion | 1 April 2017 |
| Estimated completion | 5 May 2018 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Endoscopic clipping of diverticula
- Follow-up colonoscopy
Conditions studied
- Diverticular Disease — all drugs for Diverticular Disease →
Sponsor
King's College Hospital NHS Trust
Who can join
18 and older, any sex, with Diverticular Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Diverticular bleeding is the most common cause of acute lower gastrointestinal bleeding (LGIB) in Western populations. Although self-limited in 85% of cases, some patients may require hospitalization with blood transfusion and emergent intervention, with significant associated morbidity and mortality. Up to 25% of patients with an initial bleeding episode will have subsequent episodes. Diverticula form at weak points along the colon wall, where the vasa recta enter the circular muscle layer of the colon. Diverticular bleeding is attributed to thinning of the blood vessels as they cross over the dome of a diverticulum. Endoscopic clipping of actively bleeding colonic diverticula has been recognized as a safe and effective treatment for acute LGIB since the mid1990s. Patients selected would have had previous colonoscopy to exclude other causes of bleeding (e.g. angiodysplasia, colorectal cancer). The investigators propose prophylactic elective endoscopic diverticular clipping in patients who have had at least 1 episode of acute LGIB requiring hospitalization. This would involve applying endoscopic clips to the base of every diverticula in a patient's colon, such that any bleeding source would effectively be excluded. The investigators would later reevaluate patients for colonoscopic appearance of diverticula to assess their diverticular disease. The investigators hypothesize that patients undergoing endoscopic diverticular clipping will not have repeat episodes of bleeding.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02094456
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02094456 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by King's College Hospital NHS Trust
- Last refreshed: 13 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02094456.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing