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

University of Electronic Science and Technology of China (UESTC)

Status: Unknown

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Procedure: Fluorescence angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT04229524

2001

Details and patient eligibility

About

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.

Enrollment: 246 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

angiographic intervention group

Experimental group

Description:

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.

Treatment:

Procedure: Fluorescence angiography

control group

No Intervention group

Description:

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.