Clinical trial · Observational
Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org
Benchmarking Outcomes in Pancreatoduodenectomy With Portal Vein Resection - WhippleBenchmarks.Org
NCT04053998CI-TRIAL-00048419completedClinicalTrials.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 WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.
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 |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreaticoduodenectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreaticoduodenectomy with portal vein resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Mortality rate
- timeFrame
- 12 months
- description
- Death due to any cause postoperatively
- measure
- Morbidity rate
- timeFrame
- 12 months
- description
- Classified according to the Clavien-Dindo Classification of postoperative complications.
- measure
- Morbidity assessed according to the Comprehensive Complications Index® (CCI®)
- timeFrame
- 12 months
- description
- The Comprehensive Complications Index® (CCI®) reports the cumulative postoperative morbidity, a novel metric which measures the overall morbidity on a scale from 0 (no complications) to 100 (death).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Center Eligibility Criteria * High volume centers from ≥3 continents * Minimum 50 cases of pancreatic surgery per year or 150 cases within 3 years * Published in the area of pancreas surgery * Prospective database available Patient Eligibility Criteria Inclusion Criteria: * Adults ≥ 18 years * Resectable malignant or benign diseases (i.e. all indications) * Open pancreaticoduodenectomy (all techniques allowed) with concurrent portal vein resection Exclusion Criteria: * Patients \< 18 years * Pancreatic resections other than pancreaticoduodenectomy and portal vein resection * Pancreaticoduodenectomy with arterial reconstruction * Laparoscopic or robotic pancreaticoduodenectomy
References
Publications (3)
- BACKGROUNDSanchez-Velazquez P, Muller X, Malleo G, Park JS, Hwang HK, Napoli N, Javed AA, Inoue Y, Beghdadi N, Kalisvaart M, Vigia E, Walsh CD, Lovasik B, Busquets J, Scandavini C, Robin F, Yoshitomi H, Mackay TM, Busch OR, Hartog H, Heinrich S, Gleisner A, Perinel J, Passeri M, Lluis N, Raptis DA, Tschuor C, Oberkofler CE, DeOliveira ML, Petrowsky H, Martinie J, Asbun H, Adham M, Schulick R, Lang H, Koerkamp BG, Besselink MG, Han HS, Miyazaki M, Ferrone CR, Fernandez-Del Castillo C, Lillemoe KD, Sulpice L, Boudjema K, Del Chiaro M, Fabregat J, Kooby DA, Allen P, Lavu H, Yeo CJ, Barroso E, Roberts K, Muiesan P, Sauvanet A, Saiura A, Wolfgang CL, Cameron JL, Boggi U, Yoon DS, Bassi C, Puhan MA, Clavien PA. Benchmarks in Pancreatic Surgery: A Novel Tool for Unbiased Outcome Comparisons. Ann Surg. 2019 Aug;270(2):211-218. doi: 10.1097/SLA.0000000000003223. PMID 30829701
- BACKGROUNDRaptis DA, Mettler T, Fischer MA, Patak M, Lesurtel M, Eshmuminov D, de Rougemont O, Graf R, Clavien PA, Breitenstein S. Managing multicentre clinical trials with open source. Inform Health Soc Care. 2014 Mar;39(2):67-80. doi: 10.3109/17538157.2013.812647. PMID 24517456
- DERIVEDRaptis DA, Sanchez-Velazquez P, Machairas N, Sauvanet A, Rueda de Leon A, Oba A, Groot Koerkamp B, Lovasik B, Chan C, Yeo CJ, Bassi C, Ferrone CR, Kooby D, Moskal D, Tamburrino D, Yoon DS, Barroso E, de Santibanes E, Kauffmann EF, Vigia E, Robin F, Casciani F, Burdio F, Belfiori G, Malleo G, Lavu H, Hartog H, Hwang HK, Han HS, Poves I, Rosado ID, Park JS, Lillemoe KD, Roberts KJ, Sulpice L, Besselink MG, Abuawwad M, Del Chiaro M, de Santibanes M, Falconi M, D'Silva M, Silva M, Abu Hilal M, Qadan M, Sell NM, Beghdadi N, Napoli N, Busch ORC, Mazza O, Muiesan P, Muller PC, Ravikumar R, Schulick R, Powell-Brett S, Abbas SH, Mackay TM, Stoop TF, Gallagher TK, Boggi U, van Eijck C, Clavien PA, Conlon KCP, Fusai GK. Defining Benchmark Outcomes for Pancreatoduodenectomy With Portomesenteric Venous Resection. Ann Surg. 2020 Nov;272(5):731-737. doi: 10.1097/SLA.0000000000004267. PMID 32889866