International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

• Conditions: Pancreatitis; Pancreatic Neoplasms
• Interventions: Procedure: Pancreatic surgery

• Registration Number: NCT04652271
• Lead Sponsor: Royal Free Hospital NHS Foundation Trust

Brief Summary

"Snapshot" study worldwide over 3 months in 2021. Provide a verified record of true morbidity and mortality. Identify modifiable predicting factors of outcome. Obtain PubMed citable co-authorship,

Detailed Description

The PancreasGroup.org team is conducting a "snapshot" clinical study investigating the outcomes of pancreatic surgery worldwide. This "collaborative" model for snapshot clinical studies is a well-established approach for assessing current practice in a short period of time.

There will be 3 months of prospective enrolment and 3 months follow up within a 12-month frame. The study will provide highly valuable data on outcomes after pancreatic surgery.

The investigators are aiming at providing a verified record of true morbidity and mortality in consecutive unselected patients. This way the investigators will help identify relevant, modifiable predicting factors for outcome after pancreatic surgery.

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-03
• Status Verified: 2021-09
• Study Start: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

• All indications (including benign and malignant)
• Open, laparoscopic or robotic.
• Elective or emergency.
• Partial or total pancreatectomies.
• Pancreatic tumour enucleations.
• Procedures with concomitant vascular or other organ resections.
• Pancreatic duct drainage procedures (e.g. Frey, Puestow, or Beger)
• Adults 18 years of age or older.

Exclusion Criteria

• Pancreas or islet cell transplantation.
• Transcutaneous or transgastric imaging-guided ablation (e.g. RFA) or electroporation (e.g. NanoKnife).
• Endoscopic (e.g. endoscopic retrograde cholangiopancreatography, stent or lithotripsy) procedures.
• Endoscopic transgastric and surgical necrosectomies excluded.
• Patients less than 18 years of age excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing pancreatic surgery	Pancreatic surgery	Patients undergoing any type of pancreatic surgery.

Primary Outcome Measures

Name	Time	Method
Mortality	90 days postoperatively	Postoperative death

Secondary Outcome Measures

Name	Time	Method
Morbidity	90 days postoperatively	Postoperative complication rates classified according to Clavien-Dindo