search
Back to results

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

Primary Purpose

Duodenal Tumor

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic resection: CSP/p-CSP
Endoscopic resection: EMR/EPMR
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duodenal Tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CSP/p-CSP

EMR/EPMR

Arm Description

Prospective allocation

Historical control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2022
Last Updated
June 18, 2022
Sponsor
Shanghai Zhongshan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05428553
Brief Title
CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors
Acronym
CSP; EMR
Official Title
Endoscopic Cold Snare Polypectomy Versus Endoscopic Mucosal Resection of Superficial Non-ampullary Duodenal Tumors (SNADTs) (>6mm, Sessile) - A Prospective Multicenter Historically Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duodenal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CSP/p-CSP
Arm Type
Experimental
Arm Description
Prospective allocation
Arm Title
EMR/EPMR
Arm Type
Active Comparator
Arm Description
Historical control
Intervention Type
Procedure
Intervention Name(s)
Endoscopic resection: CSP/p-CSP
Intervention Description
Patients in the experimental arm will be assigned to receive CSP/p-CSP.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic resection: EMR/EPMR
Intervention Description
Patients in the historical control arm have already finished EMR/EPMR
Primary Outcome Measure Information:
Title
Adverse events
Description
iIntraoperative and postoperative adverse events; through medical records and telephone follow up
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Postoperative adverse events
Description
postoperative adverse events; through medical records and telephone follow up
Time Frame
2 weeks
Title
Clinically significant delayed bleeding
Description
Leading to emergency room visit, readmission, or intervention
Time Frame
2 weeks
Title
Delayed perforation
Description
Image confirmed
Time Frame
2 weeks
Title
Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation
Description
Not responsive to water flushing and clips are needed
Time Frame
intra-procedural
Title
Intraoperative deep mural injury
Description
stage III/IV/V
Time Frame
intra-procedural
Title
En bloc resection
Description
specimen resected in one piece
Time Frame
intra-procedural
Title
Procedure duration
Description
the entire duration of the procedure, not including ascending of the scope and looking for the lesions
Time Frame
intra-procedural
Title
Recurrence after 6 months
Description
confirmed by colonoscopy
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Cost
Description
total cost of hospitalization
Time Frame
2 weeks
Title
Number of treatment after technical failure
Description
through medical records and telephone follow up
Time Frame
6 months
Title
Number of clips
Description
number of clips used to close the wound
Time Frame
intra-procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin-Yang Liu, MD,MPH
Phone
13661802849
Email
liu.xinyang@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Quan-Lin Li, MD,PhD
Phone
13564671882
Email
li.quanlin@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Hong Zhou, MD,PhD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin-Yang Liu, MD,MPH
Phone
86-13661802849
Email
shmulxy@163.com
First Name & Middle Initial & Last Name & Degree
Ping-Hong Zhou, MD,FASGE
First Name & Middle Initial & Last Name & Degree
Quan-Llin Li, MD,PhD
First Name & Middle Initial & Last Name & Degree
Xin-Yang Liu, MD,MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs