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
1 other identifier
interventional
246
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJune 9, 2020
June 1, 2020
1.1 years
January 6, 2020
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
angiographic intervention group
EXPERIMENTALEnrolled 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.
control group
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed esophageal squamous cell carcinoma and and potential resection;
- Intend to undergo thoracic laparoscopy combined with three-incision esophageal cancer radical operation;
- The stomach is used as an esophageal substitute for reconstruction;
- Enrolled patients will adopt the esophagus bed pathway and round neck anastomosis method;
- Have a performance status of 0 or 1 on the ECOG Performance Scale; Adequate organ function;
- Be willing and able to provide written informed consent/assent for the trial.
You may not qualify if:
- Histologically confirmed non-squamous cell carcinoma of the esophagus ;
- The ECOG score of patient's physics \>1;
- Patients who use other organs instead of the esophagus;
- Patients with vascular arch injury and need vascular anastomosis;
- Patients with multiple complications such as heart disease or diabetes;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041, China
Related Publications (1)
He W, Li Z, Deng X, Zheng K, Wang C, Peng L, Han Y, Leng X, Zhou Q. Fluorescence quantitative assessment of blood perfusion in the gastric conduit to reduce anastomotic leakage after esophagectomy: a randomized controlled trial. Surg Endosc. 2025 Oct;39(10):6644-6654. doi: 10.1007/s00464-025-12093-6. Epub 2025 Aug 20.
PMID: 40835759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director,Head of Thoracic Surgery
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 18, 2020
Study Start
June 1, 2020
Primary Completion
June 30, 2021
Study Completion
December 31, 2021
Last Updated
June 9, 2020
Record last verified: 2020-06