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Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Superficial Mucosal Lesion

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ESTD

ESD

About this trial

This is an interventional treatment trial for Esophageal Superficial Mucosal Lesion focused on measuring Endoscopic submucosal dissection, Endoscopic submucosal tunnelling dissection, procedure time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥18 years;
Biopsy confirmed early esophageal cancer and high-grade intraepithelial neoplasia (HGIN)which were eligible for conventional ESD indications;
Suspected localized mucosal lesions detected by endoscopy.

Exclusion Criteria:

Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
The ASA classification of physical status ≥ 4 as judged by the investigator.
Severe hepatic disease or renal disease
Ability to understand and the willingness to sign a written informed consent document.
Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
Haemorrhagic disorder.
Patients who had a history of esophagectomy or a recurrent lesion.
Planned treatment with: warfarin (including other vitamin K antagonists), cisapride,phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus,theophylline, lidocaine, nifedipine.
Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
Known or suspected alcohol, drug or medication abuse.
Any condition associated with poor compliance as judged by the investigator.
Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
Involvement in the planning and conduct of the study. Previous enrollment in the present study

Sites / Locations

Xijing Hospital of Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ESTD group

ESD group

Arm Description

Use tunnelling method during ESD operation

Use traditional method during ESD operation

Outcomes

Primary Outcome Measures

The procedure time

Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.

Secondary Outcome Measures

The rate of bleeding during operation

The hemorrhage observed during the operation

The rate of injury to the muscular layer

The injury to the muscular layer observed during the operation

Full Information

NCT ID

NCT03404921

First Posted

January 13, 2018

Last Updated

July 15, 2019

Sponsor

Xijing Hospital of Digestive Diseases

Collaborators

Peking University Cancer Hospital & Institute, Tongji Hospital, First Affiliated Hospital of Suzhou Medical College, Shanghai Zhongshan Hospital, First Affiliated Hospital Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT03404921

Brief Title

Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma

Official Title

Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma: a Prospective Multicenter Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

Collaborators

Peking University Cancer Hospital & Institute, Tongji Hospital, First Affiliated Hospital of Suzhou Medical College, Shanghai Zhongshan Hospital, First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.

Detailed Description

This multicenter, prospective, randomized, controlled study aims to evaluate the efficacy and safety of the tunnel technique in ESD of superficial esophageal squamous cell carcinoma (ESCC). Specifically the tunnel technique would be compared to conventional method on the procedure time and the muscular layer injury rate in patients scheduled for ESD with indication of ESCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Superficial Mucosal Lesion

Keywords

Endoscopic submucosal dissection, Endoscopic submucosal tunnelling dissection, procedure time

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

The operator only understands the operation method required by the patient and is unaware of the observation indicators

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ESTD group

Arm Type

Experimental

Arm Description

Use tunnelling method during ESD operation

Arm Title

ESD group

Arm Type

Other

Arm Description

Use traditional method during ESD operation

Intervention Type

Procedure

Intervention Name(s)

ESTD

Intervention Description

During the ESTD procedure,after marking and submucosal injection, incisions were made at both the anal and oral sides of the lesion, and the submucosa under the lesion was then dissected to create a tunnel between the distal and proximal incisions. When the endscope reached the lower incision, the distal end of the esophageal lumen could be visualized , then two lateral mucosal incisions were made, thus completing the ESD procedure.

Intervention Type

Procedure

Intervention Name(s)

ESD

Intervention Description

The ESD procedure involved marking,injection,circumferential cutting, submucosal dissection.

Primary Outcome Measure Information:

Title

The procedure time

Description

Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.

Time Frame

day 1

Secondary Outcome Measure Information:

Title

The rate of bleeding during operation

Description

The hemorrhage observed during the operation

Time Frame

day 1

Title

The rate of injury to the muscular layer

Description

The injury to the muscular layer observed during the operation

Time Frame

day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥18 years; Biopsy confirmed early esophageal cancer and high-grade intraepithelial neoplasia (HGIN)which were eligible for conventional ESD indications; Suspected localized mucosal lesions detected by endoscopy. Exclusion Criteria: Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator. The ASA classification of physical status ≥ 4 as judged by the investigator. Severe hepatic disease or renal disease Ability to understand and the willingness to sign a written informed consent document. Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator. Haemorrhagic disorder. Patients who had a history of esophagectomy or a recurrent lesion. Planned treatment with: warfarin (including other vitamin K antagonists), cisapride,phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus,theophylline, lidocaine, nifedipine. Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator. Known or suspected alcohol, drug or medication abuse. Any condition associated with poor compliance as judged by the investigator. Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment. Involvement in the planning and conduct of the study. Previous enrollment in the present study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiguo Liu

Organizational Affiliation

Xijing Hospital of Digestive Disease

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital of Digestive Diseases

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35461890

Citation

Fan X, Wu Q, Li R, Chen W, Xie H, Zhao X, Zhu S, Fan C, Li J, Liu M, Liu Z, Han Y. Clinical benefit of tunnel endoscopic submucosal dissection for esophageal squamous cancer: a multicenter, randomized controlled trial. Gastrointest Endosc. 2022 Sep;96(3):436-444. doi: 10.1016/j.gie.2022.04.016. Epub 2022 Apr 22.

Results Reference

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Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma

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