PancreatoduodenectomyPaMIvOPNCT04381702
Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy
An observational study of Pancreatoduodenectomy, run by University Hospital, Montpellier.
Trial summary
Aim of the study : To determine the morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD). Methods : This is a monocentric retrospective study based on a prospectively maintained clinical database. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatoduodenectomy
- What is being tested?
- Pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Oct 2019
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication
Who may be able to join
- Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication
Who cannot join
- -reject the study protocol
About this study
Official title: Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience
Aim of the study :
To determine the morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD).
Methods :
This is a monocentric retrospective study based on a prospectively maintained clinical database. The study included 28 consecutive patients operated, between January 2016 and March 2019, of Laparoscopic pancreaticoduodenectomy (LPD) that we compared to 62 patients operated with the classical open approach by the same surgeon before the first laparoscopic resection at our institution.
Read the detailed description
The progress achieved over the last 20 years and the growing experience of visceral surgeons in minimally invasive surgery allow us today to embark on increasingly complex surgeries.
Laparoscopic surgery has even become the gold standard approach for many interventions, whether for bariatric functional surgery, reflux surgery, pelvic static disorder surgery, but also for tumor surgery such as colorectal cancer, esophageal or tail of the pancreas.
However, there are still interventions which, due to their technical difficulty, do not find unanimous consensus among the international scientific community for a possible minimally invasive approach.
The close contact of the pancreatic gland with the splenomesaraic trunk making laparoscopic dissection difficult with risk of uncontrollable bleeding.
It seems, however, that the finesse of the dissection and coagulation instruments and the precision of today's optics make it possible to approach the head of the pancreas in completely satisfactory conditions.
Several centers around the world have developed the LPD technique with encouraging results in terms of perioperative mortality without showing any advantage over laparotomy.
At the Montpellier University Hospital we started performing Laparoscopic pancreaticoduodenectomy (LPD) at the beginning of 2016.
The aim of this study is to assess, on the one hand, the morbimortality and the quality of surgery linked to the development of this relatively new technique in a reference center for pancreatic surgery and on the other hand to assess a possible learning curve effect within our experience.
- Conditions
- Pancreatoduodenectomy
- Being tested
- Pancreatoduodenectomy
- Keywords
- Pancreatoduodenectomy, Benign or malign pathology, Mini-invasive approach, Morbimortality, Laparoscopic approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreatoduodenectomyProcedure or surgery
Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Patients with an open approach | Patients requiring pancreatoduodenectomy and operated with an open approach : All consecutive patients requiring pancreato-duodenectomies for benign or malignant pathology before the first laparoscopic pancreaticoduodenectomy. Receives: Procedure: Pancreatoduodenectomy | |
| Patients with a laparoscopic approach | Patients requiring pancreatoduodenectomy and operated with a laparoscopic approach : All consecutive patients requiring pancreato-duodenectomies for benign or malignant pathology operated with a laparoscopic approach. Receives: Procedure: Pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD)
Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD) :Overall morbidity (according to Clavien Dindo Classification)
Measured: 90 postoperative days
Secondary outcomes (2)
Number of lymph nodes removed
Number of lymph nodes removed
Measured: 14 postoperative days
Margins of excision
Margins of excision R0, R1, R2
Measured: 14 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Aug 2016
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatoduodenectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- REGIS SOUCHE, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381702
- Sponsor's protocol ID
- RECHMPL19_0253
- Acronym
- PaMIvOP
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience
- ClinicalTrials.gov ID
- NCT04381702
- Acronym / sponsor ID
- PaMIvOP / RECHMPL19_0253
- Conditions
- Pancreatoduodenectomy
- Keywords
- Pancreatoduodenectomy, Benign or malign pathology, Mini-invasive approach, Morbimortality, Laparoscopic approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 11 May 2020 (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.
Aim of the study :
To determine the morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD).
Methods :
This is a monocentric retrospective study based on a prospectively maintained clinical database. The study included 28 consecutive patients operated, between January 2016 and March 2019, of Laparoscopic pancreaticoduodenectomy (LPD) that we compared to 62 patients operated with the classical open approach by the same surgeon before the first laparoscopic resection at our institution.
Detailed description
The progress achieved over the last 20 years and the growing experience of visceral surgeons in minimally invasive surgery allow us today to embark on increasingly complex surgeries.
Laparoscopic surgery has even become the gold standard approach for many interventions, whether for bariatric functional surgery, reflux surgery, pelvic static disorder surgery, but also for tumor surgery such as colorectal cancer, esophageal or tail of the pancreas.
However, there are still interventions which, due to their technical difficulty, do not find unanimous consensus among the international scientific community for a possible minimally invasive approach.
The close contact of the pancreatic gland with the splenomesaraic trunk making laparoscopic dissection difficult with risk of uncontrollable bleeding.
It seems, however, that the finesse of the dissection and coagulation instruments and the precision of today's optics make it possible to approach the head of the pancreas in completely satisfactory conditions.
Several centers around the world have developed the LPD technique with encouraging results in terms of perioperative mortality without showing any advantage over laparotomy.
At the Montpellier University Hospital we started performing Laparoscopic pancreaticoduodenectomy (LPD) at the beginning of 2016.
The aim of this study is to assess, on the one hand, the morbimortality and the quality of surgery linked to the development of this relatively new technique in a reference center for pancreatic surgery and on the other hand to assess a possible learning curve effect within our experience.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with an open approach | – | Procedure: PancreatoduodenectomyPatients requiring pancreatoduodenectomy and operated with an open approach : All consecutive patients requiring pancreato-duodenectomies for benign or malignant pathology before the first laparoscopic pancreaticoduodenectomy. |
| Patients with a laparoscopic approach | – | Procedure: PancreatoduodenectomyPatients requiring pancreatoduodenectomy and operated with a laparoscopic approach : All consecutive patients requiring pancreato-duodenectomies for benign or malignant pathology operated with a laparoscopic approach. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication
Key inclusion criteria (1 listed)
- Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication
Key exclusion criteria (1 listed)
- -reject the study 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 |
|---|---|---|
| PancreatoduodenectomyOpen or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis | Procedure or surgery | Patients with a laparoscopic approach, Patients with an open approach |
Primary outcome
Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD)
Time frame: 90 postoperative days
Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD) :Overall morbidity (according to Clavien Dindo Classification)
2 secondary outcomes
Number of lymph nodes removed
Time frame: 14 postoperative days
Margins of excision
Time frame: 14 postoperative days
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 12 May 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
REGIS SOUCHE study director
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatoduodenectomy, run by University Hospital, Montpellier.
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 1 inclusion and 1 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) (time frame: 90 postoperative days). 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 12 May 2020.