International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

PancreasGroup.Org - International Pancreatic Surgery Outcomes Study

"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,

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Neoplasms; Pancreatitis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

• 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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients undergoing pancreatic resection by surgeons at their respective centres are eligible for study inclusion.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Collaborators: Massachusetts General Hospital; University College London Hospitals
• 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

Publications and helpful links

Helpful Links

• The official website of PancreasGroup.org
• The R statistical package for analysis

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: pancreatic surgery; snapshot; global surgery; predictors; outcomes
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Pancreatitis
• Other Study ID Numbers: 20203109-PG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: PancreasGroup.org is a collaboration of all surgeons contributing data as equal partners. Each surgeon contributing data has access to analysis files of the entire database at any time point and the right to propose analyses and publish data as long as every surgeon contributing data are included as a group author in every publication and have an opportunity to review the data prior to submission. Each collaborator has access to their own data in a form of excel export file without requiring permission or approval by the PancreasGroup.org management committee.
• IPD Sharing Time Frame: The data will become available after the first and main publication of PancreasGroup.org. They will be available for at least 10 years.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No