PancreasMRPNCT00918853
Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas
A study testing resection of adenocarcinoma of the head of the pancreas in people with Pancreas and Adenocarcinoma, run by Institut Paoli-Calmettes at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas, Adenocarcinoma
- What is being tested?
- resection of adenocarcinoma of the head of the pancreas
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 20 sitesFrance
- Study dates
- Aug 2008to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Chu D'Angers
Angers
Chu de Bordeaux
Bordeaux
Hopital Ambroise Pare
Boulogne
Chu de Clermont-Ferrand
Clermont-Ferrand
Hopital Beaujon
Clichy
Hopital Henri Mondor
Créteil
Hopital de L'Antiquaille
Lyon
Hopital de La Croix-Rousse
Lyon
Hospices Civils de Lyon
Lyon
Chu La Conception
Marseille
Institut Paoli-Calmettes
Marseille
Centre Val D'Aurelle Paul Lamarque
Montpellier
Hotel Dieu
Nantes
Hopital Cochin
Paris
Hopital Pitie-Salpetriere
Paris
Hopital Tenon
Paris
Hopitial Saint Antoine
Paris
Hopital Pontchaillou
Rennes
Hopitaux Universitaires de Strasbourg
Strasbourg
Chu Purpan
Toulouse
About this study
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.
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.
Read the 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.
- Conditions
- Pancreas, Adenocarcinoma
- Being tested
- resection of adenocarcinoma of the head of the pancreas
- Keywords
- pancreas, adenocarcinoma
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection of adenocarcinoma of the head of the pancreasProcedure or surgery
quality standard for the resection of adenocarcinoma of the head of the pancreas
| Study group | Role | What they receive |
|---|---|---|
| resection for adenocarcinoma | Experimental | quality standard resection for adenocarcinoma of the head of the pancreas Receives: Procedure: resection of adenocarcinoma of the head of the pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of the invasion of the margins measured in millimetres on the overall survival
Measured: 4 years
Secondary outcomes (1)
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PancreasStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Robert DELPERO, PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918853
- Sponsor's protocol ID
- MRP/IPC 2007-005
- Other IDs
- ID-RCB 2007-A01326-47
- Acronym
- MRP
- Status last verified
- Mar 2013
- First submitted
- 9 Jun 2009
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28953554Delpero 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.
PubMed 23464850
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00918853
- Acronym / sponsor ID
- MRP / MRP/IPC 2007-005
- Conditions
- Pancreas, Adenocarcinoma
- Keywords
- pancreas, adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| resection for adenocarcinoma | Experimental | Procedure: resection of adenocarcinoma of the head of the pancreasquality standard resection for adenocarcinoma of the head of the pancreas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A head of the pancreas tumor compatible with adenocarcinoma diagnosis
- tumor apparently removable
- patient aged from 18 to older
- signed consent
- pregnancy, breast feeding
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resection of adenocarcinoma of the head of the pancreasquality standard for the resection of adenocarcinoma of the head of the pancreas | Procedure or surgery | resection for adenocarcinoma |
Primary outcome
Prognostic value of the invasion of the margins measured in millimetres on the overall survival
Time frame: 4 years
1 secondary outcome
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
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Derived from this study: PubMed 28953554Delpero 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.
- Derived from this study: PubMed 23464850Delpero 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.
- OFFICIAL WEB SITE OF THE SPONSORLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Robert DELPERO, PhD principal investigator
Institut Paoli-Calmettes
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resection of adenocarcinoma of the head of the pancreas in people with Pancreas and Adenocarcinoma, run by Institut Paoli-Calmettes at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of the invasion of the margins measured in millimetres on the overall survival (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918853, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.