Anastomotic Leak Testing in Gastrectomy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292496
• Other study ID #: 2020001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2023
• Source: Nanchong Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 13, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anastomotic Leak
• Gastric Cancer
• Gastroscopy
• Stomach Neoplasms
• Surgery
• Testing, Reality

Intervention

Procedure:
• Introperative leak testing
After anastomosis was completed. We test the integrity of anastomosis intraoperatively.

Locations

Country	Name	City	State
China	Yunhong Tian	Nanchong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Nanchong Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative surgical complications	Any surgical complication that occured postoperatively	3 months