Oncologic Impact of Pancreatic Fistula

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

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

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| who developed POPF<br>Patients undergone curative distal pancreatectomy for PDAC who developed POPF | |
| who did not develop POPF<br>Patients undergone curative distal pancreatectomy for PDAC who did not develop POPF | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinically relevant pancreatic fistula, pancreatic leak, pancreatic cancer, left pancreatectomy, distal pancreatectomy, oncologic outcome, pancreatic cancer recurrence