Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

Completed

• Conditions: Pancreaticoduodenectomy; Pancreatic Neoplasms

• Registration Number: NCT04053998
• Lead Sponsor: Royal Free Hospital NHS Foundation Trust

Brief Summary

The WhippleBenchmark 2 Collaborative study aims at defining benchmark criteria for best achievable outcomes after pancreaticoduodenectomy with portal vein resection.

Detailed Description

Pancreatoduodenectomy (PD) with portal vein resection (PVR) is performed for the achievement of complete resection (R0) in patients with locally advanced pancreatic head lesions. Despite most commonly performed in high-volume pancreatic surgery centers by experienced surgeons, best achievable outcomes, such as morbidity and mortality, following such complex procedure remain unknown.

The aim is to conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following duodenopancreatectomy (DP) with portal vein resection (PVR).

Data collection and study design are based on to the well established standardized reporting for benchmarking (Sánchez-Velázquez et. al. Ann Surg, February 2019 ).

This multicenter cohort study will include all consecutive pancreaticoduodenectomies with portal vein resections from at least 20 high volume centers performing over 50 pancreatic operations per year or 150 cases within 3 years from at least 3 continents over a period of 10 years (2009-2019). Every center included in the study must have a prospective database from which data can be collected as well as previous publications critically reporting on their outcome.

Study Timeline

• Study Start: 2019-08-09
• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-20
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1462

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality rate	12 months	Death due to any cause postoperatively
Morbidity rate	12 months	Classified according to the Clavien-Dindo Classification of postoperative complications.
Morbidity assessed according to the Comprehensive Complications Index® (CCI®)	12 months	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 Outcome Measures

Name	Time	Method
Pancreatic fistula rates	12 months	reported according to both the International Study Group of Pancreatic Fistula (ISGPF) and Clavien-Dindo classification.
Hospital readmission rate	12 months	Any hospital readmission to the primary or other peripheral hospitals
Disease free survival rate	Up to 10 years postoperatively	Disease recurrence

Trial Locations

Locations (2)

Royal Free Hospital; 🇬🇧 London, United Kingdom

Parc de Salut Mar; 🇪🇸 Barcelona, Spain