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NCT04652271 Clinical Trial

International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

Pancreatic Neoplasms Clinical Trial

Official title:
PancreasGroup.Org - International Pancreatic Surgery Outcomes Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04652271
Other study ID # 20203109-PG
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2021
Est. completion date March 31, 2022

Study information
Verified date September 2021
Source Royal Free Hospital NHS Foundation Trust
Contact Guiseppe K Fusai, MD, MS
Phone +442077940500
Email g.fusai@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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,

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 3500
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Pancreatic surgery
Open, laparoscopic or robotic surgery of the pancreas

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Royal Free Hospital NHS Foundation Trust Massachusetts General Hospital, University College London Hospitals

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Postoperative death 90 days postoperatively
Secondary Morbidity Postoperative complication rates classified according to Clavien-Dindo 90 days postoperatively
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