Back to resultsQuantitative Assessment of Blood Supply in the Gastic Conduit With Fluorescence Angiography for Esophageal Reconstruction
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fluorescence angiography
Sponsored by
About this trial
This is an interventional prevention trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, blood supply, anastomotic fistula, fluorescence angiography
Eligibility Criteria
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.
Sites / Locations
- Sichuan Cancer Hospital and Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
angiographic intervention group
control group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04229524
First Posted
January 6, 2020
Last Updated
June 4, 2020
Sponsor
Sichuan Cancer Hospital and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04229524
Brief Title
Quantitative Assessment of Blood Supply in the Gastic Conduit With Fluorescence Angiography for Esophageal Reconstruction
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma, blood supply, anastomotic fistula, fluorescence angiography
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
angiographic intervention group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Fluorescence angiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of anastomotic fistula
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenwu He, M.D.
Phone
+8613350055340
Email
wenwu_he@126.com
Facility Information:
Facility Name
Sichuan Cancer Hospital and Research Institute
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenwu He, M.D.
Phone
+8613350055340
Email
wenwu_he@126.com
12. IPD Sharing Statement
Learn more about this trial
Quantitative Assessment of Blood Supply in the Gastic Conduit With Fluorescence Angiography for Esophageal Reconstruction
We'll reach out to this number within 24 hrs