Endoscopic Ultrasound Guided Colorectal ESD and Traditional Colorectal ESD Surgery

NCT ID: NCT06076382

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2024-12-30

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.

Conditions

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Colorectal Endoscopic Submucosal Dissection(ESD) Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

endoscopic ultrasound guided colorectal ESD surgery

Intervention Type 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 traditional colorectal ESD surgery group

the traditional colorectal ESD surgery

Group Type ACTIVE_COMPARATOR

the traditional colorectal ESD surgery

Intervention Type PROCEDURE

The control group underwent injection and dissection directly.

Interventions

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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.

Intervention Type PROCEDURE

the traditional colorectal ESD surgery

The control group underwent injection and dissection directly.

Intervention Type PROCEDURE

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Dong Yang

Assisted Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Xu, professor

Role: CONTACT

18844097668

Dong Yang, doctor

Role: CONTACT

Facility Contacts

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Dong Yang, Master

Role: primary

Other Identifiers

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130026

Identifier Type: -

Identifier Source: org_study_id

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