Neuroendocrine TumorsNCT04780737
Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis
An observational study of Neuroendocrine Tumors and Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Surgery, Gut Tumor
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Jul 2020
- How long will I take part?
- 5 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: For each patient sex, age, comorbidity, presence of symptoms, type of surgery (emergency or elective), ENETS TNM stage, WHO 2019 grading of the primary tumor, type of resection (R0/1 vs. R2), administration of SSA therapy, duration of follow-up, were collected
Who may be able to join
- patients with a diagnosis of Si-NEN;
- resection of the primary tumor with or without concomitant cholecystectomy;
- absence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis
Who cannot join
- presence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis
About this study
To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy
Read the detailed description
This is a retrospective study based on 230 Si-NENs candidates to the primary tumor resection. Patients were divided into two arms: PC and OC. Propensity score matching was performed, reporting the d value. The primary outcome was the re-hospitalization rate for any cause. The secondary endpoints were the re-hospitalization rate for biliary stone disease (BSD), the mean number of re-hospitalization (any cause and BSD), the complication rate (all and severe), and the total costs. A P-value < 0.05 was considered significant, and NNT< 10 was considered clinically relevant.
- Conditions
- Neuroendocrine Tumors, Surgery, Gut Tumor
- Being tested
- Cholecystectomy
- Medical subject headings
- Neuroendocrine Tumors, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Laparoscopic or laparotomic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic cholecystectomy | Patient who undergo resection of primary ileal neuroendocrine tumor and contemporarly cholecystectomy Receives: Procedure: Cholecystectomy | |
| On-demand cholecystectomy | Patient resected for primary ileal neuroendocrine tumor, treated with cholecystectomy in a different operation and only if needed, for the development of biliary stone disease Receives: Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-hospitalization rate for any cause
the re-hospitalization rate for any cause after primary tumor surgery
Measured: through study completion, an average of 7 years
Secondary outcomes (5)
re-hospitalization rate for biliary stone disease
the re-hospitalization rate for biliary stone disease after primary tumor surgery
Measured: through study completion, an average of 7 years
mean number of re-hospitalization any cause
the mean number of re-hospitalization for any cause after primary tumor surgery
Measured: through study completion, an average of 7 years
mean number of re-hospitalization biliary stone disease
the mean number of re-hospitalization for biliary stone disease after primary tumor surgery
Measured: through study completion, an average of 7 years
total costs
total costs for primary tumor surgery plus any re-hospitalization
Measured: through study completion, an average of 7 years
COmplication rate
COmplication rate after primary tumor resection
Measured: through study completion, an average of 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startJan 2000
- Primary completionDec 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Enrolment
- 230 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Ingaldi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Carlo Ingaldi, MD, Principal investigator, Azienda Ospedaliero Universitaria, Ospedale S.Orsola Malpighi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780737
- Sponsor's protocol ID
- RAC 164/2017/ O/Oss
- Status last verified
- Mar 2021
- First submitted
- 8 Jan 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis
- ClinicalTrials.gov ID
- NCT04780737
- Acronym / sponsor ID
- RAC 164/2017/ O/Oss
- Conditions
- Neuroendocrine Tumors, Surgery, Gut Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jan 2000 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 3 Mar 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.
To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy
Detailed description
This is a retrospective study based on 230 Si-NENs candidates to the primary tumor resection. Patients were divided into two arms: PC and OC. Propensity score matching was performed, reporting the d value. The primary outcome was the re-hospitalization rate for any cause. The secondary endpoints were the re-hospitalization rate for biliary stone disease (BSD), the mean number of re-hospitalization (any cause and BSD), the complication rate (all and severe), and the total costs. A P-value < 0.05 was considered significant, and NNT< 10 was considered clinically relevant.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic cholecystectomy | – | Procedure: CholecystectomyPatient who undergo resection of primary ileal neuroendocrine tumor and contemporarly cholecystectomy |
| On-demand cholecystectomy | – | Procedure: CholecystectomyPatient resected for primary ileal neuroendocrine tumor, treated with cholecystectomy in a different operation and only if needed, for the development of biliary stone disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For each patient sex, age, comorbidity, presence of symptoms, type of surgery (emergency or elective), ENETS TNM stage, WHO 2019 grading of the primary tumor, type of resection (R0/1 vs. R2), administration of SSA therapy, duration of follow-up, were collected
Key inclusion criteria (3 listed)
- patients with a diagnosis of Si-NEN;
- resection of the primary tumor with or without concomitant cholecystectomy;
- absence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis
Key exclusion criteria (1 listed)
- presence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis
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 |
|---|---|---|
| CholecystectomyLaparoscopic or laparotomic cholecystectomy | Procedure or surgery | On-demand cholecystectomy, Prophylactic cholecystectomy |
Primary outcome
re-hospitalization rate for any cause
Time frame: through study completion, an average of 7 years
the re-hospitalization rate for any cause after primary tumor surgery
5 secondary outcomes
re-hospitalization rate for biliary stone disease
Time frame: through study completion, an average of 7 years
mean number of re-hospitalization any cause
Time frame: through study completion, an average of 7 years
mean number of re-hospitalization biliary stone disease
Time frame: through study completion, an average of 7 years
total costs
Time frame: through study completion, an average of 7 years
COmplication rate
Time frame: through study completion, an average of 7 years
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 3 Mar 2021.
- Individual participant dataSharing planned: Yes
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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.
Carlo Ingaldi, MD principal investigator
Azienda Ospedaliero Universitaria, Ospedale S.Orsola Malpighi
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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 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 3 Mar 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?
re-hospitalization rate for any cause (time frame: through study completion, an average of 7 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 3 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.