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Completed

NCT Number: NCT05478889

Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

Outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. This is an international multicenter propensity score matched cohort study including patients after MIPD or OPD for dCCA. Primary outcomes included overall survival (OS) and disease-free interval (DFI).

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Key information

Conditions

Distal Cholangiocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

About this study

This study is an international multicenter propensity score matched cohort study using the database of the International Study Group on non-pancreatic periAmpullary CAncer, the ISGACA consortium (www.isgaca.com), including all patients who underwent a pancreatoduodenectomy for non-pancreatic periampullary cancer. Data will be retrospectively collected. To minimize differences between groups, all the participating centers perform both OPD and MIPD and all centers meet the Miami guideline minimum volume of at least 20 MIPD per year. This study is approved by all the locals Ethical Committees (approval number from the promoting center, Comitato etico di Brescia, NP 5318 - 01.06.2022) and it will be performed according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE guideline and checklist), and the Declaration of Helsinki.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients
  • Elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021
  • Pathological confirmed dCCA

Exclusion criteria

  • Neoadjuvant chemotherapy
  • Palliative surgical procedures
  • Intraoperative detection of unresectable disease (i.e., metastasis or locally advanced disease)
  • Post-operative pathological diagnosis was other than dCCA (e.g., neuroendocrine tumor, polyposis adenoma)
  • R2 positive resection margin
  • Pregnancy
  • Missing primary endpoints

Treatment and study plan

Minimally invasive pancreatoduodenectomy

Procedure

Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques

Primary outcomes

  1. Overall survival and disease-free interval

    Time frame: 60 months

    Time-to-event data, months + occurrence of event (death or recurrence)

Secondary outcomes

  1. Major morbidity

    Time frame: 30 days or in-hospital

    Clavien-Diendo 3b-5

Sponsors and collaborators

Lead sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Other

Registry information

Official study title

Surgical and Oncological Outcome After Minimally Invasive and Open Pancreatoduodenectomy for Distal Cholangiocarcinoma: an International Propensity Score Cohort Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2022
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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