Benchmarking Outcomes in Pancreatic Surgery - WhippleBenchmarks.Org

NHS Foundation Trust

Status: Completed

Conditions: Pancreaticoduodenectomy; Pancreatic Neoplasms

Treatments: Procedure: Pancreaticoduodenectomy with portal vein resection

Study type: Observational

Funder types: Other

Identifiers

NCT04053998

WB-08-2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,462 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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