Minimally Invasive Pancreatoduodenectomy for Distal Chola... | NCT05478889

Studies
Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

NCT05478889

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Status

Completed

Last Update Posted

Jul 28, 2022Actual

Enrollment

478Actual

Phase

Not provided

Conditions

Distal Cholangiocarcinoma

Interventions

Minimally invasive pancreatoduodenectomy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Actual

Primary Completion Date

Mar 1, 2022Actual

Completion Date

Jul 1, 2022Actual

First Submitted Date

Jul 22, 2022

First Submission Date that Met QC Criteria

Jul 27, 2022

First Posted Date

Jul 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2022

Last Update Posted Date

Jul 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

478Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Minimally invasive pancreatoduodenectomy		Whipple or pylorus preserving pancreatoduodenectomy following minimally invasive approach (laparoscopic or robotic). Hybrid (hand assisted) precedures will be included in the minimally invasive cohort.	Procedure: Minimally invasive pancreatoduodenectomy
Open pancreatoduodenectomy		Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minimally invasive pancreatoduodenectomy	Procedure	Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques	Minimally invasive pancreatoduodenectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival and disease-free interval	Time-to-event data, months + occurrence of event (death or recurrence)	60 months

Secondary Outcomes

Measure	Description	Time Frame
Major morbidity	Clavien-Diendo 3b-5	30 days or in-hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adult patients after elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021 with a pathological confirmed dCCA

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moh'd Abu Hilal, MD, PhD	Fondazione Poliambulanza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Poliambulanza Istituto Ospedaliero		Brescia		25124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Upon reasonable request it would be possible to share data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided