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

Endoscopic Cold Snare Polypectomy Versus Endoscopic Mucosal Resection of Superficial Non-ampullary Duodenal Tumors (SNADTs) (>6mm, Sessile) - A Prospective Multicenter Historically Controlled Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Duodenal Tumor
• Intervention / Treatment: Procedure: Endoscopic resection: CSP/p-CSP; Procedure: Endoscopic resection: EMR/EPMR

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 Type: Interventional
• Enrollment (Anticipated): 183
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin-Yang Liu, MD,MPH; Phone Number: 13661802849; Email: liu.xinyang@zs-hospital.sh.cn
• Study Contact Backup: Name: Quan-Lin Li, MD,PhD; Phone Number: 13564671882; Email: li.quanlin@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Xin-Yang Liu, MD,MPH; Phone Number: 86-13661802849; Email: shmulxy@163.com
      • Principal Investigator: Ping-Hong Zhou, MD,FASGE
      • Sub-Investigator: Quan-Llin Li, MD,PhD
      • Sub-Investigator: Xin-Yang Liu, MD,MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSP/p-CSP; Prospective allocation	Procedure: Endoscopic resection: CSP/p-CSP; Patients in the experimental arm will be assigned to receive CSP/p-CSP.
Active Comparator: EMR/EPMR; Historical control	Procedure: Endoscopic resection: EMR/EPMR; Patients in the historical control arm have already finished EMR/EPMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	iIntraoperative and postoperative adverse events; through medical records and telephone follow up	2 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost	total cost of hospitalization	2 weeks
Number of treatment after technical failure	through medical records and telephone follow up	6 months
Number of clips	number of clips used to close the wound	intra-procedural

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Ping-Hong Zhou, MD,PhD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: June 18, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Duodenal Diseases; Duodenal Neoplasms
• Other Study ID Numbers: ShanghaiZhongshanEndoscopy1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Original data could be shared at request by email after publication
• IPD Sharing Time Frame: The data will be available after publication of the study
• IPD Sharing Access Criteria: The shared data could be available by contacting Dr. Xin-Yang Liu at shmulxy@163.com.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No