Clinical trial · Interventional
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
NCT06464978CI-TRIAL-00106831recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
Conditions
Conditions (4)
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 Leakage | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrostomy | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Stapler | Device | — | UNRESOLVED |
| Stapler Reinforcement Patch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stapler Reinforcement Patch Group
- description
- Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
- interventionNames
- Device: Stapler Reinforcement Patch
- type
- ACTIVE_COMPARATOR
- label
- Standard Stapler Group
- description
- Participants in this group will receive gastrojejunostomy with the use of standard staplers.
- interventionNames
- Device: Standard Stapler
Primary outcomes (1)
- measure
- Rate of Anastomotic Leakage
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 85 years. * Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy. * ECOG performance status of 0 or 1. * ASA (American Society of Anesthesiologists) classification of I-III. * Voluntary signed informed consent from the participant or their legal representative. Exclusion Criteria: * Evidence of potential distant metastasis found preoperatively. * History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy. * Significant contraindications for surgery (e.g., severe liver or kidney dysfunction). * Participation in any other clinical trial within the last 6 months. * Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.