Anastomotic Leak Testing in Gastrectomy

Not Applicable

Completed

• Conditions: Gastroscopy; Anastomotic Leak; Gastric Cancer; Surgery; Testing, Reality
• Interventions: Procedure: Introperative leak testing

• Registration Number: NCT04292496
• Lead Sponsor: Nanchong Central Hospital

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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-29
• Study First Posted: 2020-03-03
• Primary Completion: 2022-09-02
• Study Completion: 2023-03-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. resectable gastric carcinoma according to the eighth edition of the TNM (clinical stages I-III).
2. Eastern Cooperative Oncology Group performance status of 0 or 1.
3. American Society of Anesthesiologists class of I-III.

Exclusion Criteria

1. Patients had distant metastasis.
2. presence of obvious contraindications to surgery (e.g., liver and/or kidney function abnormalities).
3. any participation in another clinical trial within the past 6 months.
4. Previous chemotherapy or radiation therapy for any other malignancies.
5. past history of gastric resection, gastric cancer-related complications, other malignancy diagnosed within the previous 5 years,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraperative leak testing group	Introperative leak testing	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.

Primary Outcome Measures

Name	Time	Method
Anastomotic leakage	2 months	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

Name	Time	Method
Postoperative surgical complications	3 months	Any surgical complication that occured postoperatively

Trial Locations

Locations (1)

Yunhong Tian; 🇨🇳 Nanchong, Sichuan, China