A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers (MI-PD)
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|ClinicalTrials.gov Identifier: NCT03172572|
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : June 27, 2018
RATIONALE: Minimally-invasive pancreatoduodenectomy (MIPD), either laparoscopic or robot-assisted, has been suggested as a valuable alternative to open pancreatoduodenectomy (OPD). The generalizability of the current literature is, however, unknown since randomized studies are lacking, and current data are published from few, very high volume centers and selection bias with a lack of case-matched series. International studies are lacking completely.
OBJECTIVE: To compare outcomes of MIPD versus open pancreatoduodenectomy (OPD), in high-volume European pancreas centers (>10 MIPDs per year, total >20 PDs per year).
METHODS: A retrospective multicenter propensity-score matched cohort study including all consecutive patients who underwent MIPD (or MI total pancreatectomy) between January 2012 and December 2016, for pancreatic head, bile duct, or duodenal cancer or cysts except chronic pancreatitis. Predefined electronic case report forms will be disseminated amongst participating centers. Participants are responsible for their own data collection. Matching of MIPD cases (collected from participating centers) to OPD controls (extracted from Dutch and German national registries) will be based on propensity scores determined by logistic regression including preoperative variables: year of surgery, demographics, BMI, ASA, comorbidities, tumor size, tumor etiology (diagnosis), and multivisceral resection. Primary outcome is 90-day major morbidity(Clavien-Dindo ≥ 3a). Secondary outcomes are 90-day postoperative events including: pancreatic fistula, length of hospital stay, R0 (microscopically negative) resection margin, malignant lymph node ratio, days to adjuvant therapy and overall survival.
|Condition or disease||Intervention/treatment|
|Pancreatic Neoplasms Pancreas Cyst Pancreas Cancer||Procedure: Minimally invasive pancreatoduodenectomy Procedure: Open pancreatoduodenectomy|
|Study Type :||Observational|
|Actual Enrollment :||4220 participants|
|Official Title:||Outcomes After Minimally Invasive or Open Pancreatoduodenectomy in High-volume Centers; a Pan-European Retrospective Propensity-score Matched Cohort Study|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||April 30, 2018|
Indication for surgery
Procedure: Minimally invasive pancreatoduodenectomy
Laparoscopic, robot-assisted, or hybrid resection
Procedure: Open pancreatoduodenectomy
- Major morbidity [ Time Frame: 90-days ]Clavien-Dindo grade 3a-5 complications
- Pancreatic fistulae [ Time Frame: 90-days ]ISGPS 2017 definition
- Length of stay [ Time Frame: 90-days ]length of hospital stay
- Radical resection rate [ Time Frame: 90-days ]R0/R1/R2 classification
- Malignant lymph node ratio [ Time Frame: 90-days ]Malignant/ non-malignant lymph nodes
- time to adjuvant therapy [ Time Frame: 90-days ]Resection to adjuvant chemo(-radio) therapy
- Overall survival [ Time Frame: 90-days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172572