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International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

PancreasGroup.Org - International Pancreatic Surgery Outcomes Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04652271
Enrollment
3500
Registered
2020-12-03
Start date
2021-09-30
Completion date
2022-03-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms, Pancreatitis

Keywords

pancreatic surgery, snapshot, global surgery, predictors, outcomes

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,

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.

Interventions

PROCEDUREPancreatic surgery

Open, laparoscopic or robotic surgery of the pancreas

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality90 days postoperativelyPostoperative death

Secondary

MeasureTime frameDescription
Morbidity90 days postoperativelyPostoperative complication rates classified according to Clavien-Dindo

Contacts

Primary ContactGuiseppe K Fusai, MD, MS
g.fusai@nhs.net+442077940500
Backup ContactDimitri A Raptis, MD, MSc, PhD
dimitri.raptis@nhs.net+447584560889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026