Quantitative Assessment of Blood Supply in the Gastic Conduit With Fluorescence Angiography for Esophageal Reconstruction

Not Applicable

• Conditions: Esophageal Squamous Cell Carcinoma

• Registration Number: NCT04229524
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief Summary

A single-institution, randomize controlled trial is to be held to evaluate the correlation between blood supply in the gastic conduit and the incidence of anastomotic fistula during radical operation for esophageal squamous cell carcinoma by fluorescence angiography.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-12
• Study First Posted: 2020-01-18
• Status Verified: 2020-06
• Study Start: 2020-06-01
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-09
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• 1.Histologically confirmed esophageal squamous cell carcinoma and and potential resection;
• 2.Intend to undergo thoracic laparoscopy combined with three-incision esophageal cancer radical operation;
• 3.The stomach is used as an esophageal substitute for reconstruction;
• 4.Enrolled patients will adopt the esophagus bed pathway and round neck anastomosis method;
• 5.Have a performance status of 0 or 1 on the ECOG Performance Scale; Adequate organ function;
• 6.Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria

• 1.Histologically confirmed non-squamous cell carcinoma of the esophagus ;
• 2.The ECOG score of patient's physics >1;
• 3.Patients who use other organs instead of the esophagus;
• 4.Patients with vascular arch injury and need vascular anastomosis;
• 5.Patients with multiple complications such as heart disease or diabetes;
• 6.Other patients whom the medical practitioner considers inappropriate for inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of anastomotic fistula	3 months	Anastomotic fistula is defined as an anastomotic fistula or any anastomotic dehiscence or leakage of saliva from a neck wound, confirmed by gastroscopy or upper gastrointestinal angiography, or purulent discharge from the chest or mediastinal drainage catheter. In addition, in this study, occult fistula was not included in the anastomotic fistula group when invasive treatment was not required.

Trial Locations

Locations (1)

Sichuan Cancer Hospital and Research Institute; 🇨🇳 Chengdu, Sichuan, China