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International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

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ClinicalTrials.gov Identifier: NCT04652271
Recruitment Status : Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborators:
University College London Hospitals
Massachusetts General Hospital
Information provided by (Responsible Party):
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,

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PancreasGroup.Org - International Pancreatic Surgery Outcomes Study
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Mortality [ Time Frame: 90 days postoperatively ]
    Postoperative death


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 90 days postoperatively ]
    Postoperative complication rates classified according to Clavien-Dindo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients undergoing pancreatic resection by surgeons at their respective centres are eligible for study inclusion.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652271


Contacts
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Contact: Guiseppe K Fusai, MD, MS +442077940500 g.fusai@nhs.net
Contact: Dimitri A Raptis, MD, MSc, PhD +447584560889 dimitri.raptis@nhs.net

Sponsors and Collaborators
Royal Free Hospital NHS Foundation Trust
University College London Hospitals
Massachusetts General Hospital
Investigators
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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
Additional Information:
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Responsible Party: Royal Free Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04652271    
Other Study ID Numbers: 20203109-PG
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Free Hospital NHS Foundation Trust:
pancreatic surgery
snapshot
global surgery
predictors
outcomes
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases