Back to resultsAnastomotic Leak Testing in Gastrectomy
Primary Purpose
Anastomotic Leak, Gastric Cancer, Surgery
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Introperative leak testing
Sponsored by
About this trial
This is an interventional prevention trial for Anastomotic Leak
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function.
Exclusion Criteria:
- Patients had distant metastasis.
- oesophageal invasion of more than 3 cm.
- Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
- Previous chemotherapy or radiation therapy for any other malignancies.
Sites / Locations
- Yunhong Tian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intraperative leak testing group
Non-intraoperative leak testing group
Arm Description
i) the integrity of the anastomosis can be directly observed under gastroscopy. ii) the distal of Roux limb was temporarily blocked, then the bowel of anastomosis was inflated by air, following 60 milliliter methylene blue.
Non intraoperative leak testing was performed intraoperatively.
Outcomes
Primary Outcome Measures
Anastomotic leakage
all patients underwent upper gastrointestinal radiography after surgery for detecting the integrity of anastomosis. X-ray to detect the integrity of the anastomosis
Secondary Outcome Measures
Postoperative surgical complications
Any surgical complication that occured postoperatively
Full Information
NCT ID
NCT04292496
First Posted
February 28, 2020
Last Updated
March 13, 2023
Sponsor
Nanchong Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04292496
Brief Title
Anastomotic Leak Testing in Gastrectomy
Official Title
Effect of Routine Leak Testing in Radical Gastrectomy on Prevention of Postoperative Anastomotic Leak for Patients With Gastric Cancer: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
March 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanchong Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group.
Detailed Description
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group. patients underwent total gastrectomy for gastric cancer, with esophagojejunostomy reconstruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak, Gastric Cancer, Surgery, Testing, Reality, Gastroscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraperative leak testing group
Arm Type
Experimental
Arm Description
i) the integrity of the anastomosis can be directly observed under gastroscopy. ii) the distal of Roux limb was temporarily blocked, then the bowel of anastomosis was inflated by air, following 60 milliliter methylene blue.
Arm Title
Non-intraoperative leak testing group
Arm Type
No Intervention
Arm Description
Non intraoperative leak testing was performed intraoperatively.
Intervention Type
Procedure
Intervention Name(s)
Introperative leak testing
Intervention Description
After anastomosis was completed. We test the integrity of anastomosis intraoperatively.
Primary Outcome Measure Information:
Title
Anastomotic leakage
Description
all patients underwent upper gastrointestinal radiography after surgery for detecting the integrity of anastomosis. X-ray to detect the integrity of the anastomosis
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Postoperative surgical complications
Description
Any surgical complication that occured postoperatively
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ function.
Exclusion Criteria:
Patients had distant metastasis.
oesophageal invasion of more than 3 cm.
Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
Previous chemotherapy or radiation therapy for any other malignancies.
Facility Information:
Facility Name
Yunhong Tian
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Anastomotic Leak Testing in Gastrectomy
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