NCT03172572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

May 26, 2017

Last Update Submit

June 26, 2018

Conditions

Pancreatic NeoplasmsPancreas CystPancreas Cancer

Keywords

minimally invasive surgical procedurespancreas surgerypancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Major morbidity

    Clavien-Dindo grade 3a-5 complications

    90-days

Secondary Outcomes (6)

  • Pancreatic fistulae

    90-days

  • Length of stay

    90-days

  • Radical resection rate

    90-days

  • Malignant lymph node ratio

    90-days

  • time to adjuvant therapy

    90-days

  • +1 more secondary outcomes

Study Arms (1)

Indication for surgery

Solid neoplasms

Procedure: Minimally invasive pancreatoduodenectomyProcedure: Open pancreatoduodenectomy

Interventions

Minimally invasive pancreatoduodenectomyPROCEDURE

Laparoscopic, robot-assisted, or hybrid resection

Indication for surgery
Open pancreatoduodenectomyPROCEDURE

Open resection

Indication for surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • Chronic pancreatitis without suspected solid tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sjors Klompmaker

Amsterdam, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 29864089DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Cyst

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCysts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

May 26, 2017

First Posted

June 1, 2017

Study Start

February 1, 2017

Primary Completion

December 31, 2017

Study Completion

April 30, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)