An international study to investigate rates of death and illness following surgery of the pancreas

Not Applicable

Completed

Conditions: Surgery
Patients with pancreatic disease requiring surgery

Registration Number: ISRCTN95140761

Lead Sponsor: Royal Free London NHS Foundation Trust

Brief Summary: 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38743040/ (added 20/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 4223

Inclusion Criteria

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

Exclusion Criteria

1. Pancreas or islet cell transplantation
2. Transcutaneous or transgastric imaging-guided ablation (e.g. RFA) or electroporation (e.g. NanoKnife)
3. Endoscopic (e.g. ERCP, stent or lithotripsy) procedures
4. Endoscopic transgastric and surgical necrosectomies

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality rate 90 days postoperatively measured using patient records

Secondary Outcome Measures

Name	Time	Method
Morbidity as defined by the Clavien-Dindo Classification and measured by the Comprehensive Complications Index ® (CCI®) at 90 days postoperatively measured using patient records