Clinical trial · Interventional
Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clip closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Clip closure + EndoCut
- description
- Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.
- interventionNames
- Procedure: Clip closure
- type
- ACTIVE_COMPARATOR
- label
- Clip closure + Coagulation
- description
- Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.
- interventionNames
- Procedure: Clip closure
- type
- NO_INTERVENTION
- label
- No clip closure + EndoCut
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion * Patients with a ≥20mm non-pedunculated colon polyp Exclusion Criteria: * Patients with known (biopsy proven) invasive carcinoma in a potential study polyp * Pedunculated polyps (as defined by Paris Classification type Ip or Isp) * Patients with ulcerated depressed lesions (as defined by Paris Classification type III) * Patients with inflammatory bowel disease * Patients who are receiving an emergency colonoscopy * Poor general health (ASA class\>3) * Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50 * Poor bowel preparation * Pregnancy
References
Publications (3)
- DERIVEDCrockett SD, Khashab M, Rex DK, Grimm IS, Moyer MT, Rastogi A, Mackenzie TA, Pohl H; Large Polyp Study Group Consortium. Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1757-1765.e4. doi: 10.1016/j.cgh.2021.12.036. Epub 2021 Dec 28. PMID 34971811
- DERIVEDPohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Mackenzie TA, Rex DK. Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial. Gastroenterology. 2020 Jul;159(1):119-128.e2. doi: 10.1053/j.gastro.2020.03.014. Epub 2020 Mar 12. PMID 32173478
- DERIVEDPohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15. PMID 30885778