Status:
UNKNOWN
CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Duodenal Tumor
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Due to the possibility of malignant transformation of duodenal adenomatous lesions, endoscopic resection is recommended as far as possible. The European Society of endoscopy guidelines recommend cold ...
Eligibility Criteria
Inclusion
- Experimental arm: CSP/p-CSP
- Patients of age 18-75 years.
- Lesion located in the duodenum.
- Superficial non-ampullary duodenal tumors (SNADTs) (\>6mm, Sessile).
- Written informed consent.
- Benign adenomatous surface features (Kudo III / IV, JNET(Japan NBI (narrow-band imaging) Expert Team) 2a).
- Control arm: EMR/EPMR
- Patients of age 18-75 years.
- Lesion located in the duodenum.
- Superficial non-ampullary duodenal tumors (SNADTs) (\>6mm, Sessile).
- Benign adenomatous surface features (Kudo III / IV, JNET 2a).
- Received EMR/EPMR already.
- Provided written informed consent for use of clinical information.
Exclusion
- Experimental arm: CSP/p-CSP
- 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.
- History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy at the time of EMR/EPMR.
- Pregnant or breast feeding at the time of EMR/EPMR.
- Lesions involving the ampullary area.
- Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3).
- Scar of previous endoscopic procedures within 10mm around the lesion.
- Control arm: EMR/EPMR
- 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)；.
- History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy.
- Pregnant or breast feeding.
- Lesions involving the ampullary area.
- Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3).
- Scar of previous endoscopic procedures within 10mm around the lesion.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT05428553
Start Date
June 1 2022
End Date
November 30 2023
Last Update
June 23 2022
Active Locations (1)
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1
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032