Anastomotic Leak Testing in Gastrectomy

Nanchong Central Hospital

Status: Completed

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

Treatments: Procedure: Introperative leak testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04292496

2020001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups

Intraperative leak testing group

Experimental group

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.

Treatment:

Procedure: Introperative leak testing

Non-intraoperative leak testing group

No Intervention group

Description:

Non intraoperative leak testing was performed intraoperatively.