Clinical trial NCT00918853: Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas
Official title: Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas
Adenocarcinoma
Keywords: pancreas
adenocarcinoma
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.

Detailed description: Primary objective:

* Evaluation of the prognosis role of the invasion of the margins on the overall survival after a standard resection of adenocarcinoma of the head of the pancreas.

Secondary objectives:

* Evaluation of the prognosis role of the invasion:

  * Of margins on the overall survival.
  * Of each margins (distal pancreatic margin, gastric, posterior, retro-venous, retro-arterial) on the overall survival.
  * Of the ganglionic group of the superior mesenteric artery and the other nodes.

Eligibility criteria: Inclusion Criteria:

* A head of the pancreas tumor compatible with adenocarcinoma diagnosis
* tumor apparently removable
* patient aged from 18 to older
* signed consent

Non inclusion criteria:

* pregnancy, breast feeding
* patient in an urgency situation or patient with legal protection

Exclusion Criteria after surgery:

* tumor other than adenocarcinoma of the head of the pancreas.
* analysis of the margins not done with the defined criteria
* nonadhesion to the surgical protocol

Primary outcomes:
measure: Prognostic value of the invasion of the margins measured in millimetres on the overall survival
timeFrame: 4 years
Secondary outcomes:
measure: Relapse free survival: time between surgery and relapse or a right censure. The relapse is determined by clinical examination, biologic examination and imaging, which reveals metastasis or an isolated local relapse
timeFrame: 4 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu D'Angers
city: Bordeaux
country: France
facility: Chu de Bordeaux
city: Boulogne
country: France
facility: Hopital Ambroise Pare
city: Clermont-ferrand
country: France
facility: Chu de Clermont-Ferrand
city: Clichy
country: France
facility: Hopital Beaujon
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Lyon
country: France
facility: Hopital de L'Antiquaille
city: Lyon
country: France
facility: Hopital de La Croix-Rousse
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Chu La Conception
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier
country: France
facility: Centre Val D'Aurelle Paul Lamarque
city: Nantes
country: France
facility: Hotel Dieu
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Tenon
city: Paris
country: France
facility: Hopitial Saint Antoine
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: Chu Purpan
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean Robert DELPERO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delpero JR, Jeune F, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Adham M, Autret A, Poizat F, Turrini O, Boher JM. Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study. Ann Surg. 2017 Nov;266(5):787-796. doi: 10.1097/SLA.0000000000002432.
citation: Delpero JR, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Autret A, Turrini O, Monges-Ranchin G, Boher JM. Pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: a French multicentre prospective evaluation of resection margins in 150 evaluable specimens. HPB (Oxford). 2014 Jan;16(1):20-33. doi: 10.1111/hpb.12061. Epub 2013 Mar 7.