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RecruitingNCT06076382Updated Apr 12, 2024

Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery

An interventional study of endoscopic ultrasound guided colorectal ESD surgery and the traditional colorectal ESD surgery in Colorectal Endoscopic Submucosal Dissection(ESD) Surgery, sponsored by Jilin University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Jilin University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Colorectal Endoscopic Submucosal Dissection(ESD) Surgery

Keywords

  • colorectal
  • Endoscopic submucosal dissection
  • ultrasound
03

In context

Lead sponsor

Jilin University is the lead sponsor of 26 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • 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

  • Active comparator
    the traditional colorectal ESD surgery group

    the traditional colorectal ESD surgery

    Procedure: the traditional colorectal ESD surgery

Interventions

  • Procedureendoscopic 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.

  • Procedurethe traditional colorectal ESD surgery

    The control group underwent injection and dissection directly.

06

What researchers measure

Primary outcomes

  1. operating time

    from the injection to the end of dissection (minutes)

    Time frame: During surgery

  2. Measure the area of the lesion

    Measure the length and diameter of the lesion

    Time frame: During surgery

Secondary outcomes

  1. Number of propria muscle layer injuries during surgery

    record the points of propria muscle layer injuries during surgery

    Time frame: During surgery

  2. Time to first fluid diet

    Postoperative recovery: record the first time of fluid diet

    Time frame: one week after surgery

  3. Complete resection rate

    record the number of complete resection cases

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • the First Hospital of Jilin University
    Chang chun, Ji Lin 130021, China
    • Dong Yang, Master · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06076382
Lead sponsor
Jilin University
Responsible party
Dong Yang (Assisted Investigator, Jilin University) — Principal investigator
First posted
Oct 10, 2023
Start date
Mar 26, 2024
Primary completion
Dec 28, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Apr 12, 2024

Study contacts

Hong Xu, professor
Contact
18844097668@163.com
18844097668
Dong Yang, doctor
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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