International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

Study Overview

"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,

The PancreasGroup.org team is conducting a "snapshot" clinical study investigating the outcomes of pancreatic surgery worldwide. This Ȭollaborative" 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.

Pancreatic Neoplasms
Pancreatitis

PROCEDURE: Pancreatic surgery

20203109-PG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-09-14
First Submitted that Met QC Criteria 2020-11-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-09-16
First Posted (ACTUAL) 2020-12-03	Results First Posted N/A	Last Verified 2021-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
Mortality	Postoperative death	90 days postoperatively

Secondary Outcome Measures	Measure Description	Time Frame
Morbidity	Postoperative complication rates classified according to Clavien-Dindo	90 days postoperatively

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Guiseppe K Fusai, MD, MS

Phone Number: +442077940500

Email: g.fusai@nhs.net

Study Contact Backup

Name: Dimitri A Raptis, MD, MSc, PhD

Phone Number: +447584560889

Email: dimitri.raptis@nhs.net

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

University College London Hospitals
Massachusetts General Hospital

Investigators

STUDY_CHAIR: Guiseppe K Fusai, MD, MS, Royal Free Hospital London, UK

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

PancreasGroup.org Collaborative. Pancreatic surgery outcomes: multicentre prospective snapshot study in 67 countries. Br J Surg. 2024 Jan 3;111(1):znad330. doi: 10.1093/bjs/znad330.

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Clinical Trial Record