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

June 26, 2018 updated by: S (Sjors) Klompmaker, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major morbidity
Time Frame: 90-days
Clavien-Dindo grade 3a-5 complications
90-days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S (Sjors) Klompmaker, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

April 30, 2018

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (ACTUAL)

June 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W16_401#17.011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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