Pancreatic ResectionNCT03597230
Per-operative Exploration of the Peri-pancreatic Lymphatic Pathways During Pancreatic Surgical Resection
A study testing Dye in people with Pancreatic Resection, run by CHU de Reims at 1 site in France.
Trial summary
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) Pancreatic cancer has a poor prognosis. Surgical resection is the only curative treatment. Major pancreatectomies lead to high postoperative morbidity rate, up to 30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Resection
- What is being tested?
- Dye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2018to 22 Oct 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
- All patient operated on for pancreatic resection
- Patients consenting the protocol after clear and loyal explanations
Who cannot join
- history of first abdominal surgery in the upper part
- Patients with peritoneal carcinomatosis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) Pancreatic cancer has a poor prognosis. Surgical resection is the only curative treatment. Major pancreatectomies lead to high postoperative morbidity rate, up to 30%. For some tumors, limited resection are increasedly performed, but the rate of pancreatic fistula is even higher, up to 40%.
No precise "anatomic" pancreatic segmentation currently exists. If such segmentation is described, pancreatic resections, major of minor, may have better outcomes.
The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.
Read the detailed description
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters) The prognosis and life expectancy for people with pancreatic cancer remain very low (3rd cause of mortality among all cancer). Surgical resection is the only curative treatment, whenever possible. Nevertheless, major pancreatectomies lead to high postoperative morbidity rate, in particular up to 30% fistula rate. In case of parenchyma-sparing procedures, this rate is even higher, up to 40%.
One of the reasons of these high rates might be explained by the fact that pancreatic transections are currently not performed following pancreatic segmentation. If possible, resection following vascular segmentation would prevent necrosis of the transection, resection following lymphatic segmentation would improve the lymph-node dissection, and resection following pancreatic-duct segmentation would prevent leakage from pancreatic duct stump. Nevertheless, no precise "anatomic" pancreatic segmentation currently exists.
On the other hand, the lymphatic system of the pancreas is highly complex, but the quality of the lymphadenectomy during pancreatectomy is essential since the recurrences almost always occur on the lymphatic transections. A better knowledge of the peri-pancreatic lymphatic vessels is still required.
The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.
- Conditions
- Pancreatic Resection
- Being tested
- Dye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DyeOther
Also called The dye will be the blue patent, widely used for the detection of the sentinel lymph node for breast cancer
Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study and/or among similar interventions At the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| patients operated on for pancreatic resection | Experimental | All consecutive patients operated on for pancreatic resection Receives: Other: Dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node areas colored by the diffusion of the blue patent
At the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon.
Measured: 3 minutes after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start22 Oct 2018
- Primary completion22 Oct 2020 (estimated)
- Study completion22 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic ResectionStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597230
- Sponsor's protocol ID
- PO18091
- Status last verified
- Dec 2019
- First submitted
- 13 Jul 2018
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Renard Y, Perrenot C, Labrousse M, Avisse C, Rhaiem R, Piardi T, Braun M, Perez M. Exploration of peripancreatic lymphatic pathways in a live porcine model. Ann Anat. 2019 Sep;225:57-64. doi: 10.1016/j.aanat.2019.06.003. Epub 2019 Jul 5.
PubMed 31284072
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per-operative Exploration of the Peri-pancreatic Lymphatic Pathways During Pancreatic Surgical Resection
- ClinicalTrials.gov ID
- NCT03597230
- Acronym / sponsor ID
- PO18091
- Conditions
- Pancreatic Resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 22 Oct 2020 (estimated)
- Study completion
- 22 Oct 2020 (estimated)
- First posted
- 24 Jul 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.
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) Pancreatic cancer has a poor prognosis. Surgical resection is the only curative treatment. Major pancreatectomies lead to high postoperative morbidity rate, up to 30%. For some tumors, limited resection are increasedly performed, but the rate of pancreatic fistula is even higher, up to 40%.
No precise "anatomic" pancreatic segmentation currently exists. If such segmentation is described, pancreatic resections, major of minor, may have better outcomes.
The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.
Detailed description
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters) The prognosis and life expectancy for people with pancreatic cancer remain very low (3rd cause of mortality among all cancer). Surgical resection is the only curative treatment, whenever possible. Nevertheless, major pancreatectomies lead to high postoperative morbidity rate, in particular up to 30% fistula rate. In case of parenchyma-sparing procedures, this rate is even higher, up to 40%.
One of the reasons of these high rates might be explained by the fact that pancreatic transections are currently not performed following pancreatic segmentation. If possible, resection following vascular segmentation would prevent necrosis of the transection, resection following lymphatic segmentation would improve the lymph-node dissection, and resection following pancreatic-duct segmentation would prevent leakage from pancreatic duct stump. Nevertheless, no precise "anatomic" pancreatic segmentation currently exists.
On the other hand, the lymphatic system of the pancreas is highly complex, but the quality of the lymphadenectomy during pancreatectomy is essential since the recurrences almost always occur on the lymphatic transections. A better knowledge of the peri-pancreatic lymphatic vessels is still required.
The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients operated on for pancreatic resection | Experimental | Other: DyeAll consecutive patients operated on for pancreatic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patient operated on for pancreatic resection
- Patients consenting the protocol after clear and loyal explanations
Key exclusion criteria (2 listed)
- history of first abdominal surgery in the upper part
- Patients with peritoneal carcinomatosis
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 |
|---|---|---|
| DyeAlso: The dye will be the blue patent, widely used for the detection of the sentinel lymph node for breast cancerCover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study and/or among similar interventions At the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon. | Other | patients operated on for pancreatic resection |
Primary outcome
Lymph node areas colored by the diffusion of the blue patent
Time frame: 3 minutes after the injection
At the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Derived from this study: PubMed 31284072Renard Y, Perrenot C, Labrousse M, Avisse C, Rhaiem R, Piardi T, Braun M, Perez M. Exploration of peripancreatic lymphatic pathways in a live porcine model. Ann Anat. 2019 Sep;225:57-64. doi: 10.1016/j.aanat.2019.06.003. Epub 2019 Jul 5.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dye in people with Pancreatic Resection, run by CHU de Reims at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Dec 2019. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yohann RENARD (3 26 78 71 23 ext. 0033, yrenard@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node areas colored by the diffusion of the blue patent (time frame: 3 minutes after the injection). 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 NCT03597230, which also lists 1 linked publication.
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 16 Dec 2019.