PDAC of the Body and the Tail of the PancreasPOPF-DSSNCT04348084
Oncologic Impact of Pancreatic Fistula
An observational study of PDAC of the Body and the Tail of the Pancreas and CR- POPF, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PDAC of the Body and the Tail of the Pancreas, CR- POPF
- How many people
- 382 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2009to 30 Dec 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) of the body and the tail of the pancreas, undergoing DP with curative intent, over a ten-year period (from January 2009 to December 2018) in twelve European Surgical Departments were retrospectively collected from a prospective implemented database.
Who may be able to join
- patient with resectable pancreatic ductal adenocarcinoma (PDAC) of the body and the tail of the pancreas undergone surgery
Who cannot join
- metastatic diseases (including para-aortic lymph nodes involvement)
- PDAC arising from Intraductal Papillary Mucinous Neoplasms (IPMN)
- resection for premalignant lesions including high-grade Pancreatic Intraepithelial Neoplasia (PanIN) or adenocarcinoma in situ (Tis)
- histological diagnosis other than PDAC
- all R2 resections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancratic Ductal Adenocarcinoma oh the Body and the Tail : a Multicentre Retrospective Cohort Analysis / POPF-DSS (Postoperative Pancreatic Fistula - Disease Specific Survival)
Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.
Read the detailed description
POPF is the most common and feared complication after distal pancreatectomy (DP), increasing morbidity and mortality. Recent evidences suggest that POPF can also play a role in pancreatic cancer recurrence. Adult patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) of the body and tail of the pancreas, undergoing curative DP, over a ten-year period in twelve European Surgical Departments were retrospectively collected from a prospective implemented database. Cohort studied included 283 patients, 139 were men (49.1%), median age was 70 years-old (range 37-88). A total of 121 POPF were observed (42.8%), 42 of them (14.9%) were CR-POPF. Median follow-up period was 24 months (range 3-120). Although poorer in the POPF group, overall survival (OS) and disease-free survival (DFS) did not differ significantly when comparing patients with and without CR-POPF (p= 0.224 and p= 0.165, respectively). CR-POPF was not significantly associated with local or peritoneal recurrence (p=0.559 and p=0.302, respectively). Less patients after POPF (76.2% versus 83.8%) benefited from adjuvant chemotherapy but the difference was not significant (p=0.228). CR-POPF is a major complication after DP, but it did affect neither the post-operative therapeutic path nor oncologic outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.
- Keywords
- Clinically relevant pancreatic fistula, pancreatic leak, pancreatic cancer, left pancreatectomy, distal pancreatectomy, oncologic outcome, pancreatic cancer recurrence
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| who developed POPF | Patients undergone curative distal pancreatectomy for PDAC who developed POPF | |
| who did not develop POPF | Patients undergone curative distal pancreatectomy for PDAC who did not develop POPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of clinically relevant (CR-) POPF
The primary aim of this study is to assess the impact of clinically relevant (CR-) POPF on patient disease specific survival (OS and DFS) after curative distal pancreatectomy.
Measured: 10 years
Secondary outcomes (1)
identifying positive and negative prognostic factors
Secondary end-points of the analysis are aimed at identifying positive and negative prognostic factors and at investigating the role of POPF in specific site recurrence.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start30 Jan 2009
- Primary completion1 Dec 2018
- Study completion30 Dec 2018
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 PDAC of the Body and the Tail of the PancreasStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele, Cisanello University Hospital (Pisa, Italy), Reims University hospital, Rennes University Hospital, Morgagni Pierantoni Hospital, Fondazione Poliambulanza Hospital (Brescia, Italy), Grenoble Alpes University Hospital (Grenoble, France), SS. Antonio e Biagio e Cesare Arrigo Hospital (Alessandria, Italy), University of Bari, IHU Strasbourg, Hospital Centre of Luxemburg (Luxemburg)
- Responsible party
- Sponsor
- Investigators
- Fabrizio PANARO, PhD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348084
- Sponsor's protocol ID
- RECHMPL20_0213
- Acronym
- POPF-DSS
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Leon P, Giannone F, Belfiori G, Falconi M, Crippa S, Boggi U, Menonna F, Al Sadairi AR, Piardi T, Sulpice L, Gardini A, Sega V, Chirica M, Ravazzoni F, Giannandrea G, Pessaux P, de Blasi V, Navarro F, Panaro F. The Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma of the Body and the Tail: A Multicenter Retrospective Cohort Analysis. Ann Surg Oncol. 2021 Jun;28(6):3171-3183. doi: 10.1245/s10434-020-09310-y. Epub 2020 Nov 6.
PubMed 33156465
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancratic Ductal Adenocarcinoma oh the Body and the Tail : a Multicentre Retrospective Cohort Analysis / POPF-DSS (Postoperative Pancreatic Fistula - Disease Specific Survival)
- ClinicalTrials.gov ID
- NCT04348084
- Acronym / sponsor ID
- POPF-DSS / RECHMPL20_0213
- Keywords
- Clinically relevant pancreatic fistula, pancreatic leak, pancreatic cancer, left pancreatectomy, distal pancreatectomy, oncologic outcome, pancreatic cancer recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele, Cisanello University Hospital (Pisa, Italy), Reims University hospital, Rennes University Hospital, Morgagni Pierantoni Hospital, Fondazione Poliambulanza Hospital (Brescia, Italy), Grenoble Alpes University Hospital (Grenoble, France), SS. Antonio e Biagio e Cesare Arrigo Hospital (Alessandria, Italy), University of Bari, IHU Strasbourg, Hospital Centre of Luxemburg (Luxemburg)
- Study start
- 30 Jan 2009 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 15 Apr 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.
Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.
Detailed description
POPF is the most common and feared complication after distal pancreatectomy (DP), increasing morbidity and mortality. Recent evidences suggest that POPF can also play a role in pancreatic cancer recurrence. Adult patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) of the body and tail of the pancreas, undergoing curative DP, over a ten-year period in twelve European Surgical Departments were retrospectively collected from a prospective implemented database. Cohort studied included 283 patients, 139 were men (49.1%), median age was 70 years-old (range 37-88). A total of 121 POPF were observed (42.8%), 42 of them (14.9%) were CR-POPF. Median follow-up period was 24 months (range 3-120). Although poorer in the POPF group, overall survival (OS) and disease-free survival (DFS) did not differ significantly when comparing patients with and without CR-POPF (p= 0.224 and p= 0.165, respectively). CR-POPF was not significantly associated with local or peritoneal recurrence (p=0.559 and p=0.302, respectively). Less patients after POPF (76.2% versus 83.8%) benefited from adjuvant chemotherapy but the difference was not significant (p=0.228). CR-POPF is a major complication after DP, but it did affect neither the post-operative therapeutic path nor oncologic outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| who developed POPF | – | –Patients undergone curative distal pancreatectomy for PDAC who developed POPF |
| who did not develop POPF | – | –Patients undergone curative distal pancreatectomy for PDAC who did not develop POPF |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) of the body and the tail of the pancreas, undergoing DP with curative intent, over a ten-year period (from January 2009 to December 2018) in twelve European Surgical Departments were retrospectively collected from a prospective implemented database.
Key inclusion criteria (1 listed)
- patient with resectable pancreatic ductal adenocarcinoma (PDAC) of the body and the tail of the pancreas undergone surgery
Key exclusion criteria (5 listed)
- metastatic diseases (including para-aortic lymph nodes involvement)
- PDAC arising from Intraductal Papillary Mucinous Neoplasms (IPMN)
- resection for premalignant lesions including high-grade Pancreatic Intraepithelial Neoplasia (PanIN) or adenocarcinoma in situ (Tis)
- histological diagnosis other than PDAC
- all R2 resections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
impact of clinically relevant (CR-) POPF
Time frame: 10 years
The primary aim of this study is to assess the impact of clinically relevant (CR-) POPF on patient disease specific survival (OS and DFS) after curative distal pancreatectomy.
1 secondary outcome
identifying positive and negative prognostic factors
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Derived from this study: PubMed 33156465Leon P, Giannone F, Belfiori G, Falconi M, Crippa S, Boggi U, Menonna F, Al Sadairi AR, Piardi T, Sulpice L, Gardini A, Sega V, Chirica M, Ravazzoni F, Giannandrea G, Pessaux P, de Blasi V, Navarro F, Panaro F. The Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma of the Body and the Tail: A Multicenter Retrospective Cohort Analysis. Ann Surg Oncol. 2021 Jun;28(6):3171-3183. doi: 10.1245/s10434-020-09310-y. Epub 2020 Nov 6.
- Individual participant dataSharing planned: Undecided. NC
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.
Fabrizio PANARO, PhD study director
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PDAC of the Body and the Tail of the Pancreas and CR- POPF, run by University Hospital, Montpellier at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of clinically relevant (CR-) POPF (time frame: 10 years). 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 NCT04348084, 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 Apr 2020.