Anastomotic Leak Testing in Gastrectomy

November 12, 2024 updated by: Yunhong Tian, Nanchong Central Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Yunhong Tian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic leakage
Time Frame: 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
2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanchong Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

September 2, 2022

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

February 28, 2020

First Submitted That Met QC Criteria

February 29, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020001

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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