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Completed

NCT Number: NCT04292496

Anastomotic Leak Testing in Gastrectomy

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.

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Key information

Conditions

Anastomotic Leak Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Gastroscopy Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Stomach Diseases Stomach Neoplasms Surgery Testing, Reality

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yunhong Tian

Nanchong, Sichuan, 637000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Introperative leak testing

Procedure

After anastomosis was completed. We test the integrity of anastomosis intraoperatively.

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative surgical complications

    Time frame: 3 months

    Any surgical complication that occured postoperatively

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Mar 3, 2020
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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