Pancreas AdenocarcinomasNCT03714542
Prospective Evaluation of the Role of MRI in the Perioperative Management of Pancreas Adenocarcinomas
A study testing Pre- and postoperative MRI in people with Pancreas Adenocarcinomas, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The precision of MRI has improved over the past few years, in particular for the hepatobiliary and pancreatic pathologies. The role of MRI in the management of operated pancreas tumors remains nevertheless unclear and few studies have compared MRI to the actual gold standard (CT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinomas
- What is being tested?
- Pre- and postoperative MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Jun 2020
- 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
- patients over 18 years old
- indication for a PD for a resectable adenocarcinoma of the pancreatic head.
Who cannot join
- chronic pancreatitis
- absence of discernment
- patients not speaking French
- preoperative radio/chemotherapy
- patients with claustrophobia
- patients with metallic implants.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Lausanne Hospital
Lausanne, Canton of Vaud, 1010
About this study
The precision of MRI has improved over the past few years, in particular for the hepatobiliary and pancreatic pathologies. The role of MRI in the management of operated pancreas tumors remains nevertheless unclear and few studies have compared MRI to the actual gold standard (CT). Compared to CT, MRI is not only a morphologic imaging technique but also a functional imaging technique. MRI could therefore evaluate in a non-ionizing and dynamic way several important pre- and postoperative aspects after pancreaticoduodenectomy (PD). This study on the perioperative role of MRI includes 3 parts:
First, CT is known to minimize the real size of the pancreatic tumors and to underestimate the vascular invasion correlated to resectability. The preoperative determination of the resection surgical margins could be improved thanks to the high-contrast resolution of MRI.
Read more
Moreover, PD is a complex surgery encompassing a fragile anastomosis between the pancreatic parenchyma and the digestive tract. The permeability of the pancreatic anastomosis after PD remains presently unknown and has not been correlated to the clinical state of the patient. MRI associated with secretin injection allows evaluating this permeability, which cannot be done by CT due to the absence of functional evaluation.
Finally, present radiological follow-up after PD for tumors of the pancreatic head is performed with CT. The MRI performance has not been demonstrated yet in the context of follow-up. This imaging modality nevertheless offers unique specificities that are very interesting and that could be helpful for the diagnosis of recurrence.
- Conditions
- Pancreas Adenocarcinomas
- Being tested
- Pre- and postoperative MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre- and postoperative MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Pre- and postoperative MRI | Other | All patients will undergo a preoperative MRI and will have a postoperative follow-up with CT and MRI. Receives: Other: Pre- and postoperative MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the MRI precision in the delimitation of circumferential resection margins
The preoperative MRI results will be compared to the anatomopathological results.
Measured: Preoperative MRI performed up to one month before the operation date.
Secondary outcomes (6)
Evaluation of the potential correlation between the tumor size and the resection margins.
The preoperative MRI results will be compared to the anatomopathological results. Tumor size and resection margins will be measured in cm.
Measured: Preoperative MRI performed up to one month before the operation date.
Determination of the pancreatic anastomosis permeability
MRI with secretin injection
Measured: One year after the operation
Determination of the rate of exocrine insufficiency
Elastase test in the stool
Measured: One year after the operation
Correlation between anastomosis non-permeability and exocrine insufficiency.
Anastomosis non-permeability will be assessed with MRI with secretin one year after the operation. A score of permeability (number) will be appointed to determine permeability or not. Exocrine insufficiency will be defined by stool elastase measure <200 ug/g one year after the operation.
Measured: One year after the operation
Evaluation of a questionnaire for pancreas exocrine insufficiency
Measured: One year after the operation
Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PD
Comparison to the CT-scan
Measured: One year after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study startJul 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomasStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714542
- Sponsor's protocol ID
- 2016-00108
- Other IDs
- 2016
- Status last verified
- Jun 2020
- First submitted
- 5 Aug 2016
- Last updated
- 11 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Role of MRI in the Perioperative Management of Pancreas Adenocarcinomas
- ClinicalTrials.gov ID
- NCT03714542
- Acronym / sponsor ID
- 2016-00108
- Conditions
- Pancreas Adenocarcinomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 22 Oct 2018 (actual)
- 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.
The precision of MRI has improved over the past few years, in particular for the hepatobiliary and pancreatic pathologies. The role of MRI in the management of operated pancreas tumors remains nevertheless unclear and few studies have compared MRI to the actual gold standard (CT). Compared to CT, MRI is not only a morphologic imaging technique but also a functional imaging technique. MRI could therefore evaluate in a non-ionizing and dynamic way several important pre- and postoperative aspects after pancreaticoduodenectomy (PD). This study on the perioperative role of MRI includes 3 parts:
First, CT is known to minimize the real size of the pancreatic tumors and to underestimate the vascular invasion correlated to resectability. The preoperative determination of the resection surgical margins could be improved thanks to the high-contrast resolution of MRI.
Moreover, PD is a complex surgery encompassing a fragile anastomosis between the pancreatic parenchyma and the digestive tract. The permeability of the pancreatic anastomosis after PD remains presently unknown and has not been correlated to the clinical state of the patient. MRI associated with secretin injection allows evaluating this permeability, which cannot be done by CT due to the absence of functional evaluation.
Finally, present radiological follow-up after PD for tumors of the pancreatic head is performed with CT. The MRI performance has not been demonstrated yet in the context of follow-up. This imaging modality nevertheless offers unique specificities that are very interesting and that could be helpful for the diagnosis of recurrence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre- and postoperative MRI | Other | Other: Pre- and postoperative MRIAll patients will undergo a preoperative MRI and will have a postoperative follow-up with CT and MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 years old
- indication for a PD for a resectable adenocarcinoma of the pancreatic head.
Key exclusion criteria (6 listed)
- chronic pancreatitis
- absence of discernment
- patients not speaking French
- preoperative radio/chemotherapy
- patients with claustrophobia
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 |
|---|---|---|
| Pre- and postoperative MRI | Other | Pre- and postoperative MRI |
Primary outcome
Evaluation of the MRI precision in the delimitation of circumferential resection margins
Time frame: Preoperative MRI performed up to one month before the operation date.
The preoperative MRI results will be compared to the anatomopathological results.
6 secondary outcomes
Evaluation of the potential correlation between the tumor size and the resection margins.
Time frame: Preoperative MRI performed up to one month before the operation date.
Determination of the pancreatic anastomosis permeability
Time frame: One year after the operation
Determination of the rate of exocrine insufficiency
Time frame: One year after the operation
Correlation between anastomosis non-permeability and exocrine insufficiency.
Time frame: One year after the operation
Evaluation of a questionnaire for pancreas exocrine insufficiency
Time frame: One year after the operation
Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PD
Time frame: One year after the operation
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 11 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre- and postoperative MRI in people with Pancreas Adenocarcinomas, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 2 inclusion and 6 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Evaluation of the MRI precision in the delimitation of circumferential resection margins (time frame: Preoperative MRI performed up to one month before the operation date.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.