PancreaticoduodenectomyNCT04843670
Isolated Pancreatic Loop With Modified Pancreaticojejunostomy
An observational study of Pancreaticoduodenectomy, run by Université de Sousse.
Trial summary
The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- duodenopancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2020
- 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 15 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: all patients undergoing duodenopancreatectomy procedure, in the surgery department .
Who may be able to join
- age up to 30
- head of the pancreas tumor
Who cannot join
- body and tail pancreatic tumors
About this study
Official title: Modified Pancreaticojejunostomy Technique With Isolated Pancreatic Loop After Pancreaticoduodenectomy Reduces Postoperative Pancreatic Fistula: a Retrospective Study
The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD
Read the detailed description
Postoperative pancreatic fistula (POPF) is widely regarded as the most threatening complication following pancreaticoduodenectomy (PD). Its clinical impact and sequelae have been previously described and shown to contribute to the development of other morbid complications and high rates of mortality.
The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD.
Methods: We report our early experience using a modified PJ technique with an isolated pancreatic loop after after PD in 201 patients between January 2010 and December 2020.
- Conditions
- Pancreaticoduodenectomy
- Being tested
- duodenopancreatectomy
- Keywords
- Pancreaticoduodenectomy, pancreaticojejunostomy, Postoperative pancreatic fistula.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duodenopancreatectomyProcedure or surgery
resection of the head of the pancreas, the mower part of the biliary duct, and antrectomy
| Study group | Role | What they receive |
|---|---|---|
| patients operated for pancreas tumors | duodenopancreatectomy for head of the pancreas tumors Receives: Procedure: duodenopancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pancreatic fistula
level of lipase in abdominal drain after suregry
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Jan 2010
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ammar houssem, Université de Sousse
- Investigators
- ali ben ali, PROFESSOR, Study director, university of sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843670
- Sponsor's protocol ID
- U23471
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Pancreaticojejunostomy Technique With Isolated Pancreatic Loop After Pancreaticoduodenectomy Reduces Postoperative Pancreatic Fistula: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04843670
- Acronym / sponsor ID
- U23471
- Conditions
- Pancreaticoduodenectomy
- Keywords
- Pancreaticoduodenectomy, pancreaticojejunostomy, Postoperative pancreatic fistula.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Université de SousseUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Apr 2021 (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 aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD
Detailed description
Postoperative pancreatic fistula (POPF) is widely regarded as the most threatening complication following pancreaticoduodenectomy (PD). Its clinical impact and sequelae have been previously described and shown to contribute to the development of other morbid complications and high rates of mortality.
The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD.
Methods: We report our early experience using a modified PJ technique with an isolated pancreatic loop after after PD in 201 patients between January 2010 and December 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients operated for pancreas tumors | – | Procedure: duodenopancreatectomyduodenopancreatectomy for head of the pancreas tumors |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients undergoing duodenopancreatectomy procedure, in the surgery department .
Key inclusion criteria (2 listed)
- age up to 30
- head of the pancreas tumor
Key exclusion criteria (1 listed)
- body and tail pancreatic tumors
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 |
|---|---|---|
| duodenopancreatectomyresection of the head of the pancreas, the mower part of the biliary duct, and antrectomy | Procedure or surgery | patients operated for pancreas tumors |
Primary outcome
incidence of pancreatic fistula
Time frame: 10 years
level of lipase in abdominal drain after suregry
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 13 Apr 2021.
- 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.
ali ben ali, PROFESSOR study director
university of sousse
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticoduodenectomy, run by Université de Sousse.
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 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 13 Apr 2021. 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?
incidence of pancreatic fistula (time frame: 10 years). 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 13 Apr 2021.