International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

NCT ID: NCT04652271

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-03-31

Brief Summary

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"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

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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.

Conditions

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Pancreatic Neoplasms Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing pancreatic surgery

Patients undergoing any type of pancreatic surgery.

Pancreatic surgery

Intervention Type PROCEDURE

Open, laparoscopic or robotic surgery of the pancreas

Interventions

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Pancreatic surgery

Open, laparoscopic or robotic surgery of the pancreas

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College London Hospitals

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guiseppe K Fusai, MD, MS

Role: STUDY_CHAIR

Royal Free Hospital London, UK

Cristina Ferrone, MD

Role: STUDY_CHAIR

Massachusetts General Hospital, Boston, USA

Dimitri A Raptis, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital London, UK

Central Contacts

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Guiseppe K Fusai, MD, MS

Role: CONTACT

+442077940500

Dimitri A Raptis, MD, MSc, PhD

Role: CONTACT

+447584560889

References

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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.

Reference Type DERIVED
PMID: 38743040 (View on PubMed)

Related Links

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https://pancreasgroup.org/

The official website of PancreasGroup.org

https://rbiostatistics.com

The R statistical package for analysis

Other Identifiers

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20203109-PG

Identifier Type: -

Identifier Source: org_study_id

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