NCT03172572

A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers

Outcomes After Minimally Invasive or Open Pancreatoduodenectomy in High-volume Centers; a Pan-European Retrospective Propensity-score Matched Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,220 (actual)
• Sponsor: S (Sjors) Klompmaker, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Neoplasms
• Pancreas Cyst
• Pancreas Cancer

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive pancreatoduodenectomy	Laparoscopic, robot-assisted, or hybrid resection
PROCEDURE	Open pancreatoduodenectomy	Open resection

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-12-31
• Completion: 2018-04-30
• First posted: 2017-06-01
• Last updated: 2018-06-27

Locations

1 site across 1 country: Netherlands