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

NCT05428553 | Unknown

• 1 other identifier: ShanghaiZhongshanEndoscopy1
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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).

Conditions

Duodenal Tumor

Outcome Measures

Primary Outcomes (1)

• Adverse events

  iIntraoperative and postoperative adverse events; through medical records and telephone follow up

  2 weeks

Secondary Outcomes (8)

• Postoperative adverse events

  2 weeks

• Clinically significant delayed bleeding

  2 weeks

• Delayed perforation

  2 weeks

• Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation

  intra-procedural

• Intraoperative deep mural injury

  intra-procedural

Other Outcomes (3)

• Cost

  2 weeks

• Number of treatment after technical failure

  6 months

• Number of clips

  intra-procedural

Study Arms (2)

CSP/p-CSP

EXPERIMENTAL

Prospective allocation

Procedure: Endoscopic resection: CSP/p-CSP

EMR/EPMR

ACTIVE COMPARATOR

Historical control

Procedure: Endoscopic resection: EMR/EPMR

Interventions

Endoscopic resection: CSP/p-CSP PROCEDURE

Patients in the experimental arm will be assigned to receive CSP/p-CSP.

CSP/p-CSP

Endoscopic resection: EMR/EPMR PROCEDURE

Patients in the historical control arm have already finished EMR/EPMR

EMR/EPMR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Duodenal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases

Study Officials

• Ping-Hong Zhou, MD,PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin-Yang Liu, MD,MPH

CONTACT

13661802849; liu.xinyang@zs-hospital.sh.cn

Quan-Lin Li, MD,PhD

CONTACT

13564671882; li.quanlin@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: June 23, 2022
• Study Start: June 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: November 30, 2023
• Last Updated: June 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The data will be available after publication of the study
• Access Criteria: The shared data could be available by contacting Dr. Xin-Yang Liu at shmulxy@163.com.

Locations

CN (1)