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

Pancreas Cancer Clinical Trial

— MI-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172572
• Other study ID #: W16_401#17.011
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreas Cyst
• Pancreatic Cyst
• Pancreatic Neoplasms

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

External Links

•   Consortium Website