Anastomotic Leak Testing in Gastrectomy

• Sponsor: Nanchong Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04292496
• Collaborator: (none)
• Enrollment: 230
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 63
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anastomotic Leak; Gastric Cancer; Surgery; Testing, Reality; Gastroscopy	Procedure: Introperative leak testing	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Routine Leak Testing in Radical Gastrectomy on Prevention of Postoperative Anastomotic Leak for Patients With Gastric Cancer: A Randomized Controlled Trial.
• Actual Study Start Date: Sep 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Anastomotic leakage [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 Outcome Measures

1. Postoperative surgical complications [3 months]

   Any surgical complication that occured postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.

2. Eastern Cooperative Oncology Group performance status of 0 or 1.

3. Adequate organ function.

Exclusion Criteria:

1. Patients had distant metastasis.

2. oesophageal invasion of more than 3 cm.

3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.

4. Previous chemotherapy or radiation therapy for any other malignancies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yunhong Tian	Nanchong	Sichuan	China	637000

Sponsors and Collaborators

• Nanchong Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yunhong Tian, Professor, Nanchong Central Hospital
• ClinicalTrials.gov Identifier: NCT04292496
• Other Study ID Numbers: 2020001
• First Posted: Mar 3, 2020
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms; Anastomotic Leak

Study Results

No Results Posted as of Aug 23, 2022