Clinical trial NCT04348084: Oncologic Impact of Pancreatic Fistula
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PDAC of the Body and the Tail of the Pancreas
CR- POPF
Keywords: Clinically relevant pancreatic fistula
pancreatic leak
pancreatic cancer
left pancreatectomy
distal pancreatectomy
oncologic outcome
pancreatic cancer recurrence
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
name: Cisanello University Hospital (Pisa, Italy)
name: Reims University Hospital (Reims, France)
name: Rennes University Hospital, Rennes, France
name: Morgagni Pierantoni Hospital
name: Fondazione Poliambulanza Hospital (Brescia, Italy)
name: Grenoble Alpes University Hospital (Grenoble, France)
name: SS. Antonio e Biagio e Cesare Arrigo Hospital (Alessandria, Italy)
name: University of Bari
name: IHU Strasbourg (Strasbourg, France)
name: Hospital Centre of Luxemburg (Luxemburg)
First posted: 2020-04-15
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: impact of clinically relevant (CR-) POPF
timeFrame: 10 years
Secondary outcomes:
measure: identifying positive and negative prognostic factors
timeFrame: 10 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Fabrizio PANARO, PhD
role: STUDY_DIRECTOR
References:
citation: 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.