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

NCT ID: NCT03404921

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-07-31

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.

Conditions

Esophageal Superficial Mucosal Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESTD group

Use tunnelling method during ESD operation

Group Type: EXPERIMENTAL

ESTD

Intervention Type: PROCEDURE

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.

ESD group

Use traditional method during ESD operation

Group Type: OTHER

ESD

Intervention Type: PROCEDURE

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

Interventions

ESTD

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

ESD

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Suzhou Medical College

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Zhiguo Liu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiguo Liu

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Disease

Locations

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35461890 (View on PubMed)

Other Identifiers

KY20172066-1

Identifier Type: -

Identifier Source: org_study_id