Clinical trial NCT03172572: A Pan-European Study on Minimally Invasive Versus Open Pancreatoduodenectomy in High-volume Centers
Official title: Outcomes After Minimally Invasive or Open Pancreatoduodenectomy in High-volume Centers; a Pan-European Retrospective Propensity-score Matched Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Pancreas Cyst
Pancreas Cancer
Keywords: minimally invasive surgical procedures
pancreas surgery
pancreatoduodenectomy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 4220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases (minimally-invasive pancreatoduodenectomy) will be retrieved from participating high-volume centers (2012 and 2017).

Controls (open pancreatoduodenectomy) will be retrieved from German and Dutch population-based pancreatic surgery registries (2015-2017).

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Indication for open or minimally invasive pancreatoduodenectomy
* Pancreatic head, bile duct, or duodenal cancer or cysts

Exclusion Criteria:

* Chronic pancreatitis without suspected solid tumor.

Primary outcomes:
measure: Major morbidity
timeFrame: 90-days
Secondary outcomes:
measure: Pancreatic fistulae
timeFrame: 90-days
measure: Length of stay
timeFrame: 90-days
measure: Radical resection rate
timeFrame: 90-days
measure: Malignant lymph node ratio
timeFrame: 90-days
measure: time to adjuvant therapy
timeFrame: 90-days
measure: Overall survival
timeFrame: 90-days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Sjors Klompmaker
Study officials:
References:
citation: Klompmaker S, van Hilst J, Wellner UF, Busch OR, Coratti A, D'Hondt M, Dokmak S, Festen S, Kerem M, Khatkov I, Lips DJ, Lombardo C, Luyer M, Manzoni A, Molenaar IQ, Rosso E, Saint-Marc O, Vansteenkiste F, Wittel UA, Bonsing B, Groot Koerkamp B, Abu Hilal M, Fuks D, Poves I, Keck T, Boggi U, Besselink MG; European consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Outcomes After Minimally-invasive Versus Open Pancreatoduodenectomy: A Pan-European Propensity Score Matched Study. Ann Surg. 2020 Feb;271(2):356-363. doi: 10.1097/SLA.0000000000002850.