Uh Montpellier
Montpellier, 34295, France
NCT Number: NCT04348084
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.
Looking for future studies?
Notify Me18 year–85 year
All sexes
Observational
Montpellier, 34295, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 years
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.
Time frame: 10 years
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.
University Hospital, Montpellier
Other
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)
Acronym: POPF-DSS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01352962
Adnexal Diseases, Bronchial Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT05675059
Digestive System Diseases, Digestive System Neoplasms
Tampa, Florida, United States
View Trial DetailsNCT03410030
Digestive System Diseases, Digestive System Neoplasms
Scottsdale, Arizona, United States
View Trial DetailsNCT05034627
Digestive System Diseases, Digestive System Neoplasms
Portland, Oregon, United States
View Trial Details