Oncologic Impact of Pancreatic Fistula

CR- POPF Clinical Trial

— POPF-DSS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348084
• Other study ID #: RECHMPL20_0213
• Status: Completed
• Start date: January 30, 2009
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• CR- POPF
• Fistula
• Pancreatic Fistula
• PDAC of the Body and the Tail of the Pancreas

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (12)

Lead Sponsor

Collaborator

University Hospital, Montpellier

Cisanello University Hospital (Pisa, Italy), Fondazione Poliambulanza Hospital (Brescia, Italy), G.B. Morgagni-L. Pierantoni Hospital (Forli, Italy), Grenoble Alpes University Hospital (Grenoble, France), Hospital Centre of Luxemburg (Luxemburg), IHU Strasbourg (Strasbourg, France), Policlinico Bari University Hospital (Bari, Italy), Reims University Hospital (Reims, France), Rennes University Hospital, Rennes, France, San Raffaele IRCCS Hospital, Università Vita – Salute, (Milan, Italy), SS. Antonio e Biagio e Cesare Arrigo Hospital (Alessandria, Italy)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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