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

Quantitative Assessment of the Correlation Between Blood Supply in the Gastic Conduit and the Incidence of Anastomotic Fistula With Fluorescence Angiography for Esophageal Reconstruction

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Procedure: Fluorescence angiography

• Study Type: Interventional
• Enrollment (Anticipated): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: angiographic intervention group; Enrolled patients will undergo thoracoscopy combined with a three-incision esophageal carcinoma radical mastectomy and two-field (chest-abdomen) lymph node dissection.Quantitative assessment of blood supply in the gastic conduit was performed using fluoroscopy before esophagogastric anastomosis.	Procedure: Fluorescence angiography; After the tube and stomach were made during surgery, the predetermined anastomosis position was marked with sutures in advance according to the doctor's experience, and then 0.04ml / kg indocyanine green injection was injected into the central vein. Next, dynamic observation and recording of the tube-gastric anastomosis area in 136 seconds using a fluorescent imaging system with a fixed focal length till the fluorescence reaching range and intensity. If the average value of the fluorescence value of the anastomosis position is greater than 30, then the anastomosis position may be according to the original plan or moved to the proximal part. If the average fluorescence value of the predetermined anastomosis position is less than 30, the anastomosis must move to proximal part ensure anastomosis with fluorescence value at least> 30.
NO_INTERVENTION: control group; The same surgical method as the experimental group.The only difference is that the position of the gastic conduit anastomosis is determined based on the experience of the doctor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of anastomotic fistula	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.	3 months

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 12, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: fluorescence angiography; blood supply; esophageal squamous cell carcinoma; anastomotic fistula
• 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: 2001

Drug and device information, study documents

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