Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery

NCT06076382 | Recruiting DMC

• 1 other identifier: 130026
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Endoscopic Submucosal Dissection(ESD) Surgery

Keywords

colorectal; Endoscopic submucosal dissection; ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of propria muscle layer injuries during surgery

  During surgery

• Time to first fluid diet

  one week after surgery

• Complete resection rate

  1 year

Study Arms (2)

the endoscopic ultrasound guided colorectal ESD surgery group

EXPERIMENTAL

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 traditional colorectal ESD surgery group

ACTIVE COMPARATOR

the traditional colorectal ESD surgery

Procedure: the traditional colorectal ESD surgery

Interventions

endoscopic ultrasound guided colorectal ESD surgery PROCEDURE

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.

the endoscopic ultrasound guided colorectal ESD surgery group

the traditional colorectal ESD surgery PROCEDURE

The control group underwent injection and dissection directly.

the traditional colorectal ESD surgery group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Central Study Contacts

Hong Xu, professor

CONTACT

18844097668; 18844097668@163.com

Dong Yang, doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisted Investigator

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 10, 2023
• Study Start: March 26, 2024
• Primary Completion: December 28, 2024
• Study Completion: December 30, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)