Clinical trial · Interventional
Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer. A Randomized Controlled Trial
Does the Technique of Duodenal Resection Affect the Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer ? A Randomized Controlled Trial (DRTST: Duodenal Resection Tri-staple Technology)
NCT03277144CI-TRIAL-00029586DRTSTunknownN/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)
The goal of this trial is to demonstrate that the use of Tri-Staple Technology for duodenal resection during open gastrectomy for cancer is safer than the use of other conventional methods of resection/closure of the duodenum and that the incidence of duodenal fistula can be decreased to that observed after the use of this technology in Laparoscopic and robotic gastrectomy, therefore almost three times lower than that currently reported in literature. Participating centres must have an annual volume of at least 20 gastrectomies per year.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Duodenal Stump Leak | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| other conventional techniques | Other | — | UNRESOLVED |
| TST-TriStaple(3lines stapler)Technology | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TST-TriStaple(3lines stapler)Technology
- description
- During gastrectomy for gatric cancer without anastomosis with the duodenum, Duodenal Stump is closed with a TriStaple (three-lines linear stapler) Technology device.
- interventionNames
- Device: TST-TriStaple(3lines stapler)Technology
- type
- ACTIVE_COMPARATOR
- label
- OCT (other conventional techniques)
- description
- During gastrectomy for gatric cancer without anastomosis with the duodenum, Duodenal Stump is closed with conventional techniques including manual sutures and devices with only two lines of staples.
- interventionNames
- Other: other conventional techniques
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * pathologically proven malign tumor of the stomach * age of 18 to 80 years, * no history of other cancers * no history of radiotherapy in supra-mesocolic space * total or distal gastrectomy without anastomosis with the duodenum Exclusion Criteria: * emergency surgery * American Society of Anesthesiologists class \> 3 * need for combined resection of other organs * laparoscopic/robotic access * severe heart disease * liver cirrhosis * T stage \>cT4a * citology positive at preoperative laparoscopy * cM+ (clinical suspicion of distant metastasis) * cD+ (clinical suspicion of duodenal involvment)
References
Publications (20)
- BACKGROUNDInghelmann R, Grande E, Francisci S, Verdecchia A, Micheli A, Baili P, Capocaccia R, De Angelis R. Regional estimates of stomach cancer burden in Italy. Tumori. 2007 Jul-Aug;93(4):367-73. doi: 10.1177/030089160709300407. PMID 17899867
- BACKGROUNDAurello P, Bellagamba R, Rossi Del Monte S, D'Angelo F, Nigri G, Cicchini C, Ravaioli M, Ramacciato G. Apoptosis and microvessel density in gastric cancer: correlation with tumor stage and prognosis. Am Surg. 2009 Dec;75(12):1183-8. PMID 19999909
- BACKGROUNDAurello P, Magistri P, Nigri G, Petrucciani N, Novi L, Antolino L, D'Angelo F, Ramacciato G. Surgical management of microscopic positive resection margin after gastrectomy for gastric cancer: a systematic review of gastric R1 management. Anticancer Res. 2014 Nov;34(11):6283-8. PMID 25368226
- BACKGROUNDMartin RC 2nd, Jaques DP, Brennan MF, Karpeh M. Achieving RO resection for locally advanced gastric cancer: is it worth the risk of multiorgan resection? J Am Coll Surg. 2002 May;194(5):568-77. doi: 10.1016/s1072-7515(02)01116-x. PMID 12025834
- BACKGROUNDZwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390. PMID 19001484
- RESULTOrsenigo E, Bissolati M, Socci C, Chiari D, Muffatti F, Nifosi J, Staudacher C. Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer. 2014 Oct;17(4):733-44. doi: 10.1007/s10120-013-0327-x. Epub 2014 Jan 8. PMID 24399492
- RESULTCozzaglio L, Coladonato M, Biffi R, Coniglio A, Corso V, Dionigi P, Gianotti L, Mazzaferro V, Morgagni P, Rosa F, Rosati R, Roviello F, Doci R. Duodenal fistula after elective gastrectomy for malignant disease : an italian retrospective multicenter study. J Gastrointest Surg. 2010 May;14(5):805-11. doi: 10.1007/s11605-010-1166-2. Epub 2010 Feb 9.