CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors (CSP; EMR)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    183
  • sponsor
    Shanghai Zhongshan Hospital
Updated on 13 July 2022

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 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).

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 snare polypectomy for superficial non ampullary duodenal tumors (SNADT) less than 6mm in diameter, while EMR (endoscopic mucosal resection) is recommended as a first-line endoscopic resection for other larger lesions. ESD (endoscopic submucosal dissection) is not considered as the standard treatment of duodenum due to its difficult operation and high complication rate.

In recent years, CSP (cold snare polypectomy) has been widely used in the colon. CSP is a safe alternative method of directly removing polyps with snare without electrifying. Reducing electrocoagulation can reduce the damage of peripheral blood vessels and intestinal wall, leading to decreased risk of delayed bleeding and perforation. CSP has gradually replaced EMR in the resection of colorectal lesions of appropriate size.

So far, there is no reliable evidence on the safety of CSP / 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 / EPMR (endoscopic piecemeal mucosal resection).

Details
Condition Duodenal Tumor
Treatment Endoscopic resection: CSP/p-CSP, Endoscopic resection: EMR/EPMR
Clinical Study IdentifierNCT05428553
SponsorShanghai Zhongshan Hospital
Last Modified on13 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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