Anastomotic Leak Testing in Gastrectomy

NCT04292496 | Completed

• 1 other identifier: 2020001
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomotic Leak; Gastric Cancer; Surgery; Testing, Reality; Gastroscopy

Keywords

Anastomotic leakage; Gastric cancer; Leakage testing; Total gastrectomy; Gastroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative surgical complications

  3 months

Study Arms (2)

Intraperative leak testing group

EXPERIMENTAL

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

Non-intraoperative leak testing group

NO INTERVENTION

Non intraoperative leak testing was performed intraoperatively.

Interventions

Introperative leak testing PROCEDURE

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

Intraperative leak testing group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Yunhong Tian

Nanchong, Sichuan, 637000, China

Location

Related Publications (1)

• Gao Z, Luo H, Ma L, Bai D, Qin X, Bautista M, Gong L, Peng Y, Hu J, Tian Y. Efficacy and safety of anastomotic leak testing in gastric cancer: a randomized controlled trial. Surg Endosc. 2023 Jul;37(7):5265-5273. doi: 10.1007/s00464-023-10025-w. Epub 2023 Mar 27.

  PMID: 36971816 DERIVED

MeSH Terms

Conditions

Anastomotic Leak; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: September 1, 2018
• Primary Completion: September 2, 2022
• Study Completion: March 13, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

CN (1)