Clinical trial · Interventional
CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors
Endoscopic Cold Snare Polypectomy Versus Endoscopic Mucosal Resection of Superficial Non-ampullary Duodenal Tumors (SNADTs) (>6mm, Sessile) - A Prospective Multicenter Historically Controlled 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)
There is currently no reliable evidence on the safety of CSP (cold snare polypectomy) / p-CSP (piecemeal CSP) for SNADT greater than 6mm.In this prospective historical controlled study, we intend to test the role of CSP / p-CSP in the treatment of pedicle less snadt greater than 6mm compared with EMR (endoscopic mucosal resection) / EPMR (endoscopic piecemeal mucosal resection).
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 |
|---|---|---|---|
| Duodenal Tumor | Duodenal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic resection: CSP/p-CSP | Procedure | — | UNRESOLVED |
| Endoscopic resection: EMR/EPMR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CSP/p-CSP
- description
- Prospective allocation
- interventionNames
- Procedure: Endoscopic resection: CSP/p-CSP
- type
- ACTIVE_COMPARATOR
- label
- EMR/EPMR
- description
- Historical control
- interventionNames
- Procedure: Endoscopic resection: EMR/EPMR
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- 2 weeks
- description
- iIntraoperative and postoperative adverse events; through medical records and telephone follow up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Experimental arm: CSP/p-CSP 1. Patients of age 18-75 years. 2. Lesion located in the duodenum. 3. Superficial non-ampullary duodenal tumors (SNADTs) (\>6mm, Sessile). 4. Written informed consent. 5. Benign adenomatous surface features (Kudo III / IV, JNET(Japan NBI (narrow-band imaging) Expert Team) 2a). Control arm: EMR/EPMR 1. Patients of age 18-75 years. 2. Lesion located in the duodenum. 3. Superficial non-ampullary duodenal tumors (SNADTs) (\>6mm, Sessile). 4. Benign adenomatous surface features (Kudo III / IV, JNET 2a). 5. Received EMR/EPMR already. 6. Provided written informed consent for use of clinical information. Exclusion Criteria: Experimental arm: CSP/p-CSP 1. Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations according to the guidelines, or presence of coagulation disorder （PLT (platelet)\<50×10\^9 / L or INR (international normalized ratio)≥1.5) at the time of EMR/EPMR. 2. History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy at the time of EMR/EPMR. 3. Pregnant or breast feeding at the time of EMR/EPMR. 4. Lesions involving the ampullary area. 5. Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3). 6. Scar of previous endoscopic procedures within 10mm around the lesion. Control arm: EMR/EPMR 1. Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations according to the guidelines, or presence of coagulation disorder （PLT\<50×10\^9 / L or INR≥1.5)；. 2. History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy. 3. Pregnant or breast feeding. 4. Lesions involving the ampullary area. 5. Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3). 6. Scar of previous endoscopic procedures within 10mm around the lesion.
References
Publications (0)
Data not yet available