Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery

Study Overview
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Brief Summary
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A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery

Detailed Description
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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.

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

Conditions
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Colorectal Endoscopic Submucosal Dissection(ESD) Surgery

Intervention / Treatment
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* Procedure: endoscopic ultrasound guided colorectal ESD surgery
* Procedure: the traditional colorectal ESD surgery


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the endoscopic ultrasound guided colorectal ESD surgery group<br>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<br>* 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.<br>|
| Active Comparator: the traditional colorectal ESD surgery group<br>the traditional colorectal ESD surgery | Procedure: the traditional colorectal ESD surgery<br>* The control group underwent injection and dissection directly.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal, Endoscopic submucosal dissection, ultrasound