International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

Sponsor

Royal Free Hospital NHS Foundation Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04652271

Collaborator

University College London Hospitals (Other), Massachusetts General Hospital (Other)

3,500

Enrollment

6.9

Anticipated Duration (Months)

Study Details

Study Description

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,

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms Pancreatitis	Procedure: Pancreatic surgery

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 Design

Study Type:

Observational

Anticipated Enrollment :

3500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

PancreasGroup.Org - International Pancreatic Surgery Outcomes Study

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients undergoing pancreatic surgery Patients undergoing any type of pancreatic surgery.	Procedure: Pancreatic surgery Open, laparoscopic or robotic surgery of the pancreas

Arm

Intervention/Treatment

Patients undergoing pancreatic surgery

Patients undergoing any type of pancreatic surgery.

Procedure: Pancreatic surgery

Open, laparoscopic or robotic surgery of the pancreas

Outcome Measures

Primary Outcome Measures

Mortality [90 days postoperatively]
Postoperative death

Secondary Outcome Measures

Morbidity [90 days postoperatively]
Postoperative complication rates classified according to Clavien-Dindo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Royal Free Hospital NHS Foundation Trust
University College London Hospitals
Massachusetts General Hospital

Investigators

Study Chair: Guiseppe K Fusai, MD, MS, Royal Free Hospital London, UK
Study Chair: Cristina Ferrone, MD, Massachusetts General Hospital, Boston, USA
Principal Investigator: Dimitri A Raptis, MD, MSc, PhD, Royal Free Hospital London, UK