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

Sponsor

S (Sjors) Klompmaker, MD (Other)

Overall Status

Completed

CT.gov ID

NCT03172572

Collaborator

(none)

4,220

Enrollment

Location

14.9

Actual Duration (Months)

283.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms Pancreas Cyst Pancreas Cancer	Procedure: Minimally invasive pancreatoduodenectomy Procedure: Open pancreatoduodenectomy

Study Design

Study Type:

Observational

Actual Enrollment :

4220 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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 :

Feb 1, 2017

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Indication for surgery Solid neoplasms	Procedure: Minimally invasive pancreatoduodenectomy Laparoscopic, robot-assisted, or hybrid resection Procedure: Open pancreatoduodenectomy Open resection

Arm

Intervention/Treatment

Indication for surgery

Solid neoplasms

Procedure: Minimally invasive pancreatoduodenectomy

Laparoscopic, robot-assisted, or hybrid resection

Procedure: Open pancreatoduodenectomy

Open resection

Outcome Measures

Primary Outcome Measures

Major morbidity [90-days]
Clavien-Dindo grade 3a-5 complications

Secondary Outcome Measures

Pancreatic fistulae [90-days]
ISGPS 2017 definition
Length of stay [90-days]
length of hospital stay
Radical resection rate [90-days]
R0/R1/R2 classification
Malignant lymph node ratio [90-days]
Malignant/ non-malignant lymph nodes
time to adjuvant therapy [90-days]
Resection to adjuvant chemo(-radio) therapy
Overall survival [90-days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sjors Klompmaker	Amsterdam		Netherlands

Sponsors and Collaborators

S (Sjors) Klompmaker, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

S (Sjors) Klompmaker, MD, PhD Candidate, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ClinicalTrials.gov Identifier:

NCT03172572

Other Study ID Numbers:

W16_401#17.011

First Posted:

Jun 1, 2017

Last Update Posted:

Jun 27, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by S (Sjors) Klompmaker, MD, PhD Candidate, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

minimally invasive surgical procedures

pancreas surgery

pancreatoduodenectomy

Additional relevant MeSH terms:

Pancreatic Neoplasms

Pancreatic Cyst

Study Results

No Results Posted as of Jun 27, 2018