Oncologic Impact of Pancreatic Fistula (POPF-DSS)

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.

Study Overview

• Status: Completed
• Conditions: PDAC of the Body and the Tail of the Pancreas; CR- POPF

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 Type: Observational
• Enrollment (Actual): 382

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Rennes University Hospital, Rennes, France; Morgagni Pierantoni Hospital; San Raffaele IRCCS Hospital, Università Vita - Salute, (Milan, Italy); Cisanello University Hospital (Pisa, Italy); Reims University Hospital (Reims, France); Fondazione Poliambulanza Hospital (Brescia, Italy); Grenoble Alpes University Hospital (Grenoble, France); SS. Antonio e Biagio e Cesare Arrigo Hospital (Alessandria, Italy); Policlinico Bari University Hospital (Bari, Italy); IHU Strasbourg (Strasbourg, France); Hospital Centre of Luxemburg (Luxemburg)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2009
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: pancreatic cancer; distal pancreatectomy; pancreatic leak; Clinically relevant pancreatic fistula; left pancreatectomy; oncologic outcome; pancreatic cancer recurrence
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: RECHMPL20_0213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No