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

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ClinicalTrials.gov Identifier: NCT03172572
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
S (Sjors) Klompmaker, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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
Pancreatic Neoplasms Pancreas Cyst Pancreas Cancer Procedure: Minimally invasive pancreatoduodenectomy Procedure: Open pancreatoduodenectomy

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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 : February 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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

Procedure: Open pancreatoduodenectomy
Open resection




Primary Outcome Measures :
  1. Major morbidity [ Time Frame: 90-days ]
    Clavien-Dindo grade 3a-5 complications


Secondary Outcome Measures :
  1. Pancreatic fistulae [ Time Frame: 90-days ]
    ISGPS 2017 definition

  2. Length of stay [ Time Frame: 90-days ]
    length of hospital stay

  3. Radical resection rate [ Time Frame: 90-days ]
    R0/R1/R2 classification

  4. Malignant lymph node ratio [ Time Frame: 90-days ]
    Malignant/ non-malignant lymph nodes

  5. time to adjuvant therapy [ Time Frame: 90-days ]
    Resection to adjuvant chemo(-radio) therapy

  6. Overall survival [ Time Frame: 90-days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172572


Locations
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Netherlands
Sjors Klompmaker
Amsterdam, Netherlands
Sponsors and Collaborators
S (Sjors) Klompmaker, MD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: June 1, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by S (Sjors) Klompmaker, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
minimally invasive surgical procedures
pancreas surgery
pancreatoduodenectomy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Cyst
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cysts