Clinical trial · Interventional
Anastomotic Leak Testing in Gastrectomy
Efifcacy and Safety of Anastomotic Leak Testing in Gastric Cancer: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroscopy | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
| Testing, Reality | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Introperative leak testing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intraperative leak testing group
- description
- 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.
- interventionNames
- Procedure: Introperative leak testing
- type
- NO_INTERVENTION
- label
- Non-intraoperative leak testing group
- description
- Non intraoperative leak testing was performed intraoperatively.
Primary outcomes (1)
- measure
- Anastomotic leakage
- timeFrame
- 2 months
- description
- all patients underwent upper gastrointestinal radiography after surgery for detecting the integrity of anastomosis. X-ray to detect the integrity of the anastomosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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,
References
Publications (1)
- DERIVEDGao 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