Pancreatic NeoplasmsNCT04652271
International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
An observational study of Pancreatic Neoplasms and Pancreatitis, run by Royal Free Hospital NHS Foundation Trust.
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, Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Pancreatitis
- What is being tested?
- Pancreatic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 3,500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients undergoing pancreatic resection by surgeons at their respective centres are eligible for study inclusion.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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,
Read the 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.
- Conditions
- Pancreatic Neoplasms, Pancreatitis
- Being tested
- Pancreatic surgery
- Keywords
- pancreatic surgery, snapshot, global surgery, predictors, outcomes
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic surgeryProcedure or surgery
Open, laparoscopic or robotic surgery of the pancreas
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing pancreatic surgery | Patients undergoing any type of pancreatic surgery. Receives: Procedure: Pancreatic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Postoperative death
Measured: 90 days postoperatively
Secondary outcomes (1)
Morbidity
Postoperative complication rates classified according to Clavien-Dindo
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study startSep 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Guiseppe K Fusai, MD, MS, Study chair, Royal Free Hospital London, UKCristina Ferrone, MD, Study chair, Massachusetts General Hospital, Boston, USADimitri A Raptis, MD, MSc, PhD, Principal investigator, Royal Free Hospital London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652271
- Sponsor's protocol ID
- 20203109-PG
- Status last verified
- Sep 2021
- First submitted
- 26 Nov 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38743040
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PancreasGroup.Org - International Pancreatic Surgery Outcomes Study
- ClinicalTrials.gov ID
- NCT04652271
- Acronym / sponsor ID
- 20203109-PG
- Conditions
- Pancreatic Neoplasms, Pancreatitis
- Keywords
- pancreatic surgery, snapshot, global surgery, predictors, outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University College London Hospitals, Massachusetts General Hospital
- Study start
- Sep 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing pancreatic surgery | – | Procedure: Pancreatic surgeryPatients undergoing any type of pancreatic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing pancreatic resection by surgeons at their respective centres are eligible for study inclusion.
Key inclusion criteria (8 listed)
- All indications (including benign and malignant)
- Open, laparoscopic or robotic.
- Elective or emergency.
- Partial or total pancreatectomies.
- Pancreatic tumour enucleations.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic surgeryOpen, laparoscopic or robotic surgery of the pancreas | Procedure or surgery | Patients undergoing pancreatic surgery |
Primary outcome
Mortality
Time frame: 90 days postoperatively
Postoperative death
1 secondary outcome
Morbidity
Time frame: 90 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 38743040PancreasGroup.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.
- The official website of PancreasGroup.orgLink provided by the sponsor.
- The R statistical package for analysisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guiseppe K Fusai, MD, MS study chair
Royal Free Hospital London, UK
Cristina Ferrone, MD study chair
Massachusetts General Hospital, Boston, USA
Dimitri A Raptis, MD, MSc, PhD principal investigator
Royal Free Hospital London, UK
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms and Pancreatitis, run by Royal Free Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guiseppe K Fusai, MD, MS (+442077940500, g.fusai@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 90 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.