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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04229524
• Other study ID #: 2001
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: Wenwu He, M.D.
• Phone: +8613350055340
• Email: wenwu_he[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital and Research Institute	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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