Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery

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

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Endoscopic Submucosal Dissection(ESD) Surgery
• Intervention / Treatment: Procedure: endoscopic ultrasound guided colorectal ESD surgery; Procedure: the traditional colorectal ESD surgery

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Yang, doctor
• Study Contact Backup: Name: Hong Xu, professor; Phone Number: 18844097668; Email: 18844097668@163.com

Study Locations

• China
  • Ji Lin
    • Chang chun, Ji Lin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Dong Yang, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating time	from the injection to the end of dissection （minutes）	During surgery
Measure the area of the lesion	Measure the length and diameter of the lesion	During surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): December 28, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 24, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection; ultrasound; colorectal
• Other Study ID Numbers: 130026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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