Distal CholangiocarcinomaNCT05478889
Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma
An observational study of Distal Cholangiocarcinoma, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
Outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. This is an international multicenter propensity score matched cohort study including patients after MIPD or OPD for dCCA. Primary outcomes included overall survival (OS) and disease-free interval (DFI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Cholangiocarcinoma
- What is being tested?
- Minimally invasive pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 478 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 1 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients after elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021 with a pathological confirmed dCCA
Who may be able to join
- Adult patients
- Elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021
- Pathological confirmed dCCA
Who cannot join
- Neoadjuvant chemotherapy
- Palliative surgical procedures
- Intraoperative detection of unresectable disease (i.e., metastasis or locally advanced disease)
- Post-operative pathological diagnosis was other than dCCA (e.g., neuroendocrine tumor, polyposis adenoma)
- R2 positive resection margin
- Pregnancy
- Missing primary endpoints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical and Oncological Outcome After Minimally Invasive and Open Pancreatoduodenectomy for Distal Cholangiocarcinoma: an International Propensity Score Cohort Study
Outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. This is an international multicenter propensity score matched cohort study including patients after MIPD or OPD for dCCA. Primary outcomes included overall survival (OS) and disease-free interval (DFI).
Read the detailed description
This study is an international multicenter propensity score matched cohort study using the database of the International Study Group on non-pancreatic periAmpullary CAncer, the ISGACA consortium (www.isgaca.com), including all patients who underwent a pancreatoduodenectomy for non-pancreatic periampullary cancer. Data will be retrospectively collected. To minimize differences between groups, all the participating centers perform both OPD and MIPD and all centers meet the Miami guideline minimum volume of at least 20 MIPD per year. This study is approved by all the locals Ethical Committees (approval number from the promoting center, Comitato etico di Brescia, NP 5318 - 01.06.2022) and it will be performed according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE guideline and checklist), and the Declaration of Helsinki.
- Conditions
- Distal Cholangiocarcinoma
- Being tested
- Minimally invasive pancreatoduodenectomy
- Keywords
- Minimally invasive pancreatoduodenectomy, Whipple, Distal cholangiocarcinoma, Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive pancreatoduodenectomyProcedure or surgery
Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive pancreatoduodenectomy | Whipple or pylorus preserving pancreatoduodenectomy following minimally invasive approach (laparoscopic or robotic). Hybrid (hand assisted) precedures will be included in the minimally invasive cohort. Receives: Procedure: Minimally invasive pancreatoduodenectomy | |
| Open pancreatoduodenectomy | Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival and disease-free interval
Time-to-event data, months + occurrence of event (death or recurrence)
Measured: 60 months
Secondary outcomes (1)
Major morbidity
Clavien-Diendo 3b-5
Measured: 30 days or in-hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Nov 2021
- Primary completion1 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal CholangiocarcinomaStudies 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
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moh'd Abu Hilal, MD, PhD, Principal investigator, Fondazione Poliambulanza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478889
- Sponsor's protocol ID
- FPoliambulanza
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request it would be possible to share data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Oncological Outcome After Minimally Invasive and Open Pancreatoduodenectomy for Distal Cholangiocarcinoma: an International Propensity Score Cohort Study
- ClinicalTrials.gov ID
- NCT05478889
- Acronym / sponsor ID
- FPoliambulanza
- Conditions
- Distal Cholangiocarcinoma
- Keywords
- Minimally invasive pancreatoduodenectomy, Whipple, Distal cholangiocarcinoma, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 28 Jul 2022 (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.
Outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. This is an international multicenter propensity score matched cohort study including patients after MIPD or OPD for dCCA. Primary outcomes included overall survival (OS) and disease-free interval (DFI).
Detailed description
This study is an international multicenter propensity score matched cohort study using the database of the International Study Group on non-pancreatic periAmpullary CAncer, the ISGACA consortium (www.isgaca.com), including all patients who underwent a pancreatoduodenectomy for non-pancreatic periampullary cancer. Data will be retrospectively collected. To minimize differences between groups, all the participating centers perform both OPD and MIPD and all centers meet the Miami guideline minimum volume of at least 20 MIPD per year. This study is approved by all the locals Ethical Committees (approval number from the promoting center, Comitato etico di Brescia, NP 5318 - 01.06.2022) and it will be performed according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE guideline and checklist), and the Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive pancreatoduodenectomy | – | Procedure: Minimally invasive pancreatoduodenectomyWhipple or pylorus preserving pancreatoduodenectomy following minimally invasive approach (laparoscopic or robotic). Hybrid (hand assisted) precedures will be included in the minimally invasive cohort. |
| Open pancreatoduodenectomy | – | –Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients after elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021 with a pathological confirmed dCCA
Key inclusion criteria (3 listed)
- Adult patients
- Elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021
- Pathological confirmed dCCA
Key exclusion criteria (7 listed)
- Neoadjuvant chemotherapy
- Palliative surgical procedures
- Intraoperative detection of unresectable disease (i.e., metastasis or locally advanced disease)
- Post-operative pathological diagnosis was other than dCCA (e.g., neuroendocrine tumor, polyposis adenoma)
- R2 positive resection margin
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 |
|---|---|---|
| Minimally invasive pancreatoduodenectomyWhipple's procedure using minimally invasive (laparoscopic/robotic) techniques | Procedure or surgery | Minimally invasive pancreatoduodenectomy |
Primary outcome
Overall survival and disease-free interval
Time frame: 60 months
Time-to-event data, months + occurrence of event (death or recurrence)
1 secondary outcome
Major morbidity
Time frame: 30 days or in-hospital
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 28 Jul 2022.
- Individual participant dataSharing planned: Undecided. Upon reasonable request it would be possible to share data.
Related trials for Distal Cholangiocarcinoma
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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.
Moh'd Abu Hilal, MD, PhD principal investigator
Fondazione Poliambulanza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Cholangiocarcinoma, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
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 3 inclusion and 7 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 28 Jul 2022. 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 Italy. 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?
Overall survival and disease-free interval (time frame: 60 months). 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 28 Jul 2022.