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

Not Applicable

• Conditions: Duodenal Tumor

• Registration Number: NCT05428553
• Lead Sponsor: Shanghai Zhongshan Hospital

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 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).

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 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).

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-20
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-18
• Last Update Submitted: 2022-06-18
• Study First Posted: 2022-06-23
• Last Update Posted: 2022-06-23
• Primary Completion: 2023-03-31
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adverse events	2 weeks	iIntraoperative and postoperative adverse events; through medical records and telephone follow up

Secondary Outcome Measures

Name	Time	Method
Intraoperative deep mural injury	intra-procedural	stage III/IV/V
En bloc resection	intra-procedural	specimen resected in one piece
Recurrence after 6 months	6 months	confirmed by colonoscopy
Clinically significant delayed bleeding	2 weeks	Leading to emergency room visit, readmission, or intervention
Delayed perforation	2 weeks	Image confirmed
Postoperative adverse events	2 weeks	postoperative adverse events; through medical records and telephone follow up
Procedure duration	intra-procedural	the entire duration of the procedure, not including ascending of the scope and looking for the lesions
Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation	intra-procedural	Not responsive to water flushing and clips are needed

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China