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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03172572
Other study ID # W16_401#17.011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date April 30, 2018

Study information

Verified date June 2018
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 4220
Est. completion date April 30, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Minimally invasive pancreatoduodenectomy
Laparoscopic, robot-assisted, or hybrid resection
Open pancreatoduodenectomy
Open resection

Locations

Country Name City State
Netherlands Sjors Klompmaker Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
S (Sjors) Klompmaker, MD

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major morbidity Clavien-Dindo grade 3a-5 complications 90-days
Secondary Pancreatic fistulae ISGPS 2017 definition 90-days
Secondary Length of stay length of hospital stay 90-days
Secondary Radical resection rate R0/R1/R2 classification 90-days
Secondary Malignant lymph node ratio Malignant/ non-malignant lymph nodes 90-days
Secondary time to adjuvant therapy Resection to adjuvant chemo(-radio) therapy 90-days
Secondary Overall survival 90-days
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