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

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Procedure: Fluorescence angiography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: angiographic intervention group<br>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<br>* 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.<br>|
| No Intervention: control group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal squamous cell carcinoma, blood supply, anastomotic fistula, fluorescence angiography