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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04483726
Other study ID # RECHMPL19_0340
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 9, 2020
Est. completion date July 9, 2025

Study information

Verified date August 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Rationale: Several systematic reviews have suggested superior short term outcomes after minimally invasive distal pancreatectomy (MIDP) as compared to open distal pancreatectomy (ODP) for benign and pre-malignant disease. In the literature and in a recent pan-European survey, about one third of pancreatic surgeons expressed concerns regarding the oncologic safety (i.e. radical resection, lymph node retrieval and survival) of MIDP in pancreatic cancer. Most surgeons stated that a randomized trial assessing oncologic safety in MIDP vs ODP for pancreatic cancer is needed. 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 Main study parameters/endpoints: Primary outcome is the microscopically radical (R0, >1mm) resection rate. Main secondary outcomes are survival, lymph node retrieval, intraoperative outcomes (such as blood loss, operative time and conversion), postoperative outcomes (such as complications, time to functional recovery and hospital stay) and quality of life


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 9
Est. completion date July 9, 2025
Est. primary completion date April 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - = 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
minimally invasive distal pancreatectomy
Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
open distal pancreatectomy
open distal pancreatectomy

Locations

Country Name City State
France Hôpital Beaujon - APHP Clichy
France CHU Saint Eloi - Montpellier Montpellier
France Centre Hospitalier Orléans Orléans
France Institut Mutualiste Montsouris Paris
France Hôpital Paul Brousse Villejuif

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier AIDS Malignancy Consortium

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary microscopically radical resection rate R0, >1mm 1 day
Secondary survival Date of death 1 year
Secondary survival Date of death 2 years
Secondary survival Date of death 3 years
Secondary lymph node retrieval Tumor positive lymph nodes retrieved 1 day
Secondary Operative time Operative time from first incision to closure of the abdomen, minutes 1 day
Secondary Intraoperative blood loss Intraoperative blood loss, mL (suction canister and weight of gauzes) 1 day
Secondary intraoperative outcomes Total duration of the procedure, minutes 1 day
Secondary postoperative outcomes Major complications 1 day
Secondary specimen size Tumor size, mm 1 day
Secondary Specimen length Specimen length, mm 1 day
Secondary margin Distance from tumor to transection, anterior and posterior margin, mm 1 day
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