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Oncologic Impact of Pancreatic Fistula

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04348084
Acronym
POPF-DSS
Enrollment
382
Registered
2020-04-15
Start date
2009-01-30
Completion date
2018-12-30
Last updated
2020-04-16

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

Conditions

CR- POPF, PDAC of the Body and the Tail of the Pancreas

Keywords

Clinically relevant pancreatic fistula, pancreatic leak, pancreatic cancer, left pancreatectomy, distal pancreatectomy, oncologic outcome, pancreatic cancer recurrence

Brief 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.

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.

Interventions

None listed

Sponsors

IRCCS San Raffaele
CollaboratorOTHER
Cisanello University Hospital (Pisa, Italy)
CollaboratorUNKNOWN
Reims University Hospital (Reims, France)
CollaboratorUNKNOWN
Rennes University Hospital, Rennes, France
CollaboratorUNKNOWN
Morgagni Pierantoni Hospital
CollaboratorOTHER
Fondazione Poliambulanza Hospital (Brescia, Italy)
CollaboratorUNKNOWN
Grenoble Alpes University Hospital (Grenoble, France)
CollaboratorUNKNOWN
SS. Antonio e Biagio e Cesare Arrigo Hospital (Alessandria, Italy)
CollaboratorUNKNOWN
University of Bari
CollaboratorOTHER
IHU Strasbourg (Strasbourg, France)
CollaboratorUNKNOWN
Hospital Centre of Luxemburg (Luxemburg)
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

\- patient with resectable pancreatic ductal adenocarcinoma (PDAC) of the body and the tail of the pancreas undergone surgery

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
impact of clinically relevant (CR-) POPF10 yearsThe 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.

Secondary

MeasureTime frameDescription
identifying positive and negative prognostic factors10 yearsSecondary 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026