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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-31

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.

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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fluorescence angiography

Intervention Type PROCEDURE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No