NCT04483726

Brief Summary

Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail. Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints. Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC. Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted) Control: Open distal pancreatectomy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

June 23, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

July 9, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2021

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2025

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

June 23, 2020

Last Update Submit

August 18, 2022

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

pancreaspancreaticsurgeryminimally-invasivecanceradenocarcinomalaparoscopyrandomizedprospective

Outcome Measures

Primary Outcomes (1)

  • microscopically radical resection rate

    R0, \>1mm

    1 day

Secondary Outcomes (11)

  • survival

    1 year

  • survival

    2 years

  • survival

    3 years

  • lymph node retrieval

    1 day

  • Operative time

    1 day

  • +6 more secondary outcomes

Study Arms (2)

MIDP

EXPERIMENTAL

minimally invasive distal pancreatectomy

Procedure: minimally invasive distal pancreatectomy

ODP

SHAM COMPARATOR

open distal pancreatectomy

Procedure: open distal pancreatectomy

Interventions

minimally invasive distal pancreatectomyPROCEDURE

Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)

MIDP
open distal pancreatectomyPROCEDURE

open distal pancreatectomy

ODP

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years;
  • Elective indication for distal pancreatectomy for proven or suspected PDAC;
  • Upfront (without induction / down-sizing radio- and/or chemotherapy) resectable PDAC in the pancreatic body or tail;
  • The tumor can be radically resected via both minimally invasive or open surgery according to the local treating team;
  • The patient is fit to undergo both open and minimally invasive distal pancreatectomy

You may not qualify if:

  • score of American society of anaesthesiologists (ASA) \>3;
  • A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria);
  • Second malignancy necessitating resection during the same procedure;
  • Distant metastases (M1) including involved distant lymph nodes;
  • Tumor involvement or abutment of major vessels (celiac trunk\*, mesenteric artery or portomesenteric vein);
  • Pregnancy;
  • Participation in another study with interference of study outcomes.
  • Cystic lesion having undergone malignant transformation
  • the celiac trunk should be 5mm clear from tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Beaujon - APHP

Clichy, France

Location

CHU Saint Eloi - Montpellier

Montpellier, France

Location

Centre Hospitalier Orléans

Orléans, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

Hôpital Paul Brousse

Villejuif, France

Location

MeSH Terms

Conditions

NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

July 23, 2020

Study Start

July 9, 2020

Primary Completion

April 29, 2021

Study Completion

July 9, 2025

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)