Anastomotic Leak Testing in Gastrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efifcacy and Safety of Anastomotic Leak Testing in Gastric Cancer: a Randomized Controlled Trial

Conditions
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Anastomotic Leak, Gastric Cancer, Surgery, Testing, Reality, Gastroscopy

Intervention / Treatment
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* Procedure: Introperative leak testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: resectable gastric carcinoma according to the eighth edition of the TNM (clinical stages I-III). Eastern Cooperative Oncology Group performance status of 0 or 1. American Society of Anesthesiologists class of I-III. Exclusion Criteria: Patients had distant metastasis. presence of obvious contraindications to surgery (e.g., liver and/or kidney function abnormalities). any participation in another clinical trial within the past 6 months. Previous chemotherapy or radiation therapy for any other malignancies. past history of gastric resection, gastric cancer-related complications, other malignancy diagnosed within the previous 5 years,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraperative leak testing group<br>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. | Procedure: Introperative leak testing<br>* After anastomosis was completed. We test the integrity of anastomosis intraoperatively.<br>|
| No Intervention: Non-intraoperative leak testing group<br>Non intraoperative leak testing was performed intraoperatively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative surgical complications | Any surgical complication that occured postoperatively | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anastomotic leakage, Gastric cancer, Leakage testing, Total gastrectomy, Gastroscopy