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

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

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

Study Overview

• Status: Completed
• Conditions: Esophageal Superficial Mucosal Lesion
• Intervention / Treatment: Procedure: ESTD; Procedure: ESD

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ESTD group; Use tunnelling method during ESD operation	Procedure: 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.
OTHER: ESD group; Use traditional method during ESD operation	Procedure: ESD; The ESD procedure involved marking,injection,circumferential cutting, submucosal dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The procedure time	Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of bleeding during operation	The hemorrhage observed during the operation	day 1
The rate of injury to the muscular layer	The injury to the muscular layer observed during the operation	day 1

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Collaborators: Shanghai Zhongshan Hospital; Tongji Hospital; Peking University Cancer Hospital & Institute; First Affiliated Hospital Xi'an Jiaotong University; First Affiliated Hospital of Suzhou Medical College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ACTUAL): July 31, 2018

Study Registration Dates

• First Submitted: January 13, 2018
• First Submitted That Met QC Criteria: January 13, 2018
• First Posted (ACTUAL): January 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection; procedure time; Endoscopic submucosal tunnelling dissection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: KY20172066-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No