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

Esophageal Superficial Mucosal Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404921
• Other study ID #: KY20172066-1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: July 2019
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Esophageal Superficial Mucosal Lesion

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases	Beijing Cancer Hospital, First Affiliated Hospital of Suzhou Medical College, First Affiliated Hospital Xi'an Jiaotong University, Shanghai Zhongshan Hospital, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The rate of bleeding during operation	The hemorrhage observed during the operation	day 1
Secondary	The rate of injury to the muscular layer	The injury to the muscular layer observed during the operation	day 1