Clinical trial · Interventional
Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
Endoscopic Mucosal Resection (EMR) is the current standard for effective endoscopic resection of such colon adenomas. If resection is possible in one piece (so-called "en bloc" resection) then recurrence rates are low. However, most non-pedunculated polyps \>2 cm are removed in pieces ("piece-meal" resection) which leads to disease recurrence rates between 12-30%. In the March 2019 issue of Gastroenterology Bourke et al. presented that post-EMR ablation of the resection margins using soft coagulation with the tip of a resection snare reduces adenoma recurrence to 5% compared to 21% recurrence found in the control group. Hybrid Argon Plasma Coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows to lift of dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications. The study hypothesis is that routine use of hybrid Argon Plasma Coagulation (h-APC) for ablation of the post-EMR resection margins and resection surface area will reduce post-EMR adenoma recurrence to 5% or lower.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid Argon Plasma Coagulation and EMR procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group treatment h-APC and EMR
- description
- Standard endoscopic mucosal resection (EMR) technique will be used for primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection is used as per the current standard of care using a contrast agent and a lifting agent (e.g. NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique is facilitated using standard microprocessor controlled electrocautery (e.g. ERBE VIO Endocut 3-1-6). Ablation of the margin after visibly complete removal of the polyp is routinely applied. For thermal ablation hybrid APC (Erbe Hybrid APC) will be applied using standard settings on the margin and resection base. Once resection and thermal ablation is considered complete the mucosal defect can be closed with clips or another preventative measure applied to reduce the risk for post-polypectomy bleeding.
- interventionNames
- Procedure: Hybrid Argon Plasma Coagulation and EMR procedure
Primary outcomes (1)
- measure
- Post-EMR recurrence at FU1
- timeFrame
- 4 months (+- 2 months) after the index h-APC and EMR procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * All Ethnicity and race * Patient referred for endoscopic resection of all colorectal polyps non-pedunculated equal or greater 20 mm * Written informed consent Exclusion Criteria: * Patients with known (biopsy proven) invasive carcinoma in a potential study polyp * Previous partial EMR * 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 (Boston bowel prep score ≤2) * Target sign or perforation during initial EMR * Need for ESD for complete resection prior to APC * Pregnancy and breast-feeding.
References
Publications (1)
- DERIVEDMotchum L, Levenick JM, Djinbachian R, Moyer MT, Bouchard S, Taghiakbari M, Repici A, Deslandres E, von Renteln D. EMR combined with hybrid argon plasma coagulation to prevent recurrence of large nonpedunculated colorectal polyps (with videos). Gastrointest Endosc. 2022 Nov;96(5):840-848.e2. doi: 10.1016/j.gie.2022.06.018. Epub 2022 Jun 18. PMID 35724695