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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292496
Other study ID # 2020001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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,

Study Design


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
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