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

NCT03404921 | Completed

• 1 other identifier: KY20172066-1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Superficial Mucosal Lesion

Keywords

Endoscopic submucosal dissection; Endoscopic submucosal tunnelling dissection; procedure time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The rate of bleeding during operation

  day 1

• The rate of injury to the muscular layer

  day 1

Study Arms (2)

ESTD group

EXPERIMENTAL

Use tunnelling method during ESD operation

Procedure: ESTD

ESD group

OTHER

Use traditional method during ESD operation

Procedure: ESD

Interventions

ESTD 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.

ESTD group

ESD PROCEDURE

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

ESD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 35461890 DERIVED

Study Officials

• Zhiguo Liu

  Xijing Hospital of Digestive Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The operator only understands the operation method required by the patient and is unaware of the observation indicators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: January 19, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: July 31, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

CN (1)