Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery

Sponsor

Jilin University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06076382

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery

Condition or Disease	Intervention/Treatment	Phase
Colorectal Endoscopic Submucosal Dissection(ESD) Surgery	Procedure: endoscopic ultrasound guided colorectal ESD surgery Procedure: the traditional colorectal ESD surgery	N/A

Detailed Description

This study compare and analyze the efficiency of endoscopic ultrasound guided colorectal ESD surgery with traditional colorectal ESD surgery, in order to guide colorectal ESD operations.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective Randomized Controlled Study Protocol Between Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the endoscopic ultrasound guided colorectal ESD surgery group The experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. Then undergo the colorectal ESD surgery.	Procedure: endoscopic ultrasound guided colorectal ESD surgery The experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. After water injection, the lesion was scanned and (1) the direction of gravity was determined. (2) fibrosis/infiltration under the mucosa, and the fibrosis was divided into F0 (no fibrosis), F1 (cold fibrosis), or F2 (severe fibrosis). (3) The lesion was divided into nine compartments. Mark submucosal fibrosis/infiltration sites, according to nine compartments. (4) Based on the results of endoscopic ultrasound scanning of the lesion, the surgeon draw up surgical approach and perform injection and dissection.
Active Comparator: the traditional colorectal ESD surgery group the traditional colorectal ESD surgery	Procedure: the traditional colorectal ESD surgery The control group underwent injection and dissection directly.

Arm

Intervention/Treatment

Experimental: the endoscopic ultrasound guided colorectal ESD surgery group

The experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. Then undergo the colorectal ESD surgery.

Procedure: endoscopic ultrasound guided colorectal ESD surgery

The experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. After water injection, the lesion was scanned and (1) the direction of gravity was determined. (2) fibrosis/infiltration under the mucosa, and the fibrosis was divided into F0 (no fibrosis), F1 (cold fibrosis), or F2 (severe fibrosis). (3) The lesion was divided into nine compartments. Mark submucosal fibrosis/infiltration sites, according to nine compartments. (4) Based on the results of endoscopic ultrasound scanning of the lesion, the surgeon draw up surgical approach and perform injection and dissection.

Active Comparator: the traditional colorectal ESD surgery group

the traditional colorectal ESD surgery

Procedure: the traditional colorectal ESD surgery

The control group underwent injection and dissection directly.

Outcome Measures

Primary Outcome Measures

operating time [During surgery]
from the injection to the end of dissection （minutes）
Measure the area of the lesion [During surgery]
Measure the length and diameter of the lesion

Secondary Outcome Measures

Number of propria muscle layer injuries during surgery [During surgery]
record the points of propria muscle layer injuries during surgery
Time to first fluid diet [one week after surgery]
Postoperative recovery: record the first time of fluid diet
Complete resection rate [1 year]
record the number of complete resection cases

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cases in our hospital who require colorectal ESD surgery
Colorectal lesions（laterally spreading tumor）.

Exclusion Criteria:

Laterally spreading tumor but not nodular mixed type(LST-G-M)
Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Hospital of Jilin University	Chang chun	Ji Lin	China	130021

Sponsors and Collaborators

Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong Yang, Assisted Investigator, Jilin University

ClinicalTrials.gov Identifier:

NCT06076382

Other Study ID Numbers:

130026

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dong Yang, Assisted Investigator, Jilin University

colorectal

Endoscopic submucosal dissection

ultrasound

Study Results

No Results Posted as of Oct 10, 2023