Skip to content

Anastomotic Leak Testing in Gastrectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04292496
Enrollment
148
Registered
2020-03-03
Start date
2018-09-01
Completion date
2023-03-13
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

PROCEDUREIntroperative leak testing

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

Sponsors

Nanchong Central Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Anastomotic leakage2 monthsall patients underwent upper gastrointestinal radiography after surgery for detecting the integrity of anastomosis. X-ray to detect the integrity of the anastomosis

Secondary

MeasureTime frameDescription
Postoperative surgical complications3 monthsAny surgical complication that occured postoperatively

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026