Polyp GallbladderNCT04762797
Management Strategy of Polypoid Lesions of the Gallbladder
An observational study of Polyp Gallbladder, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
We retrospectively review a single-center cohort of gallbladder polyps from January 2015 to May 2020. Univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polyp Gallbladder
- What is being tested?
- Non
- How many people
- 672 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: surgical candidates of laparoscopic cholecystectomy or laparoscopic polypectomy.
Who may be able to join
- Surgical indications for LC included polyp diameter over 10 millimeters, or polyps accompanied by GB stones, or consideration of neoplastic polyps. Surgical indications for GB-preserving surgery included GB with normal emptying function and polyp diameter smaller than 10 millimeters, or consideration of benign non-neoplastic polyps, or asymptomatic polyps.
Who cannot join
- Those do not fit for laparoscopic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management Strategy of Polypoid Lesions of the Gallbladder: a Single-center Retrospective Cohort Study
We retrospectively review a single-center cohort of gallbladder polyps from January 2015 to May 2020. Univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. Also, a comparison was conducted between laparoscopic cholecystectomy (LC) and laparoscopic polypectomy (LP) to explore factors affecting surgeons' decision on LC or LP.
- Conditions
- Polyp Gallbladder
- Being tested
- Non
- Keywords
- gallbladder polyp; laparoscopic cholecystectomy; polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NonOther
This is a retrospective study, without intervention.
| Study group | Role | What they receive |
|---|---|---|
| Non-neoplastic group | Gallbladder polyps with pathological diagnosis of cholesterol polyps or inflammatory polyps are classified into "Non-neoplastic group". Receives: Other: Non | |
| Neoplastic group | Gallbladder polyps pathologically diagnosed as adenocarcinoma, adenoma, adenomyosis, or other malignancies are classified into "Neoplastic group". Receives: Other: Non |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological diagnosis of polyps
Pathological diagnosis of polyps
Measured: Up to two weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2015
- Primary completion31 May 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 Polyp GallbladderStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Qu, Doctor, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762797
- Sponsor's protocol ID
- PUMCHTF3
- Status last verified
- Jan 2015
- First submitted
- 17 Feb 2021
- Last updated
- 21 Feb 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Strategy of Polypoid Lesions of the Gallbladder: a Single-center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04762797
- Acronym / sponsor ID
- PUMCHTF3
- Conditions
- Polyp Gallbladder
- Keywords
- gallbladder polyp; laparoscopic cholecystectomy; polypectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Feb 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.
We retrospectively review a single-center cohort of gallbladder polyps from January 2015 to May 2020. Univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. Also, a comparison was conducted between laparoscopic cholecystectomy (LC) and laparoscopic polypectomy (LP) to explore factors affecting surgeons' decision on LC or LP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-neoplastic group | – | Other: NonGallbladder polyps with pathological diagnosis of cholesterol polyps or inflammatory polyps are classified into "Non-neoplastic group". |
| Neoplastic group | – | Other: NonGallbladder polyps pathologically diagnosed as adenocarcinoma, adenoma, adenomyosis, or other malignancies are classified into "Neoplastic group". |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- surgical candidates of laparoscopic cholecystectomy or laparoscopic polypectomy.
Key inclusion criteria (1 listed)
- Surgical indications for LC included polyp diameter over 10 millimeters, or polyps accompanied by GB stones, or consideration of neoplastic polyps. Surgical indications for GB-preserving surgery included GB with normal emptying function and polyp diameter smaller than 10 millimeters, or consideration of benign non-neoplastic polyps, or asymptomatic polyps.
Key exclusion criteria (1 listed)
- Those do not fit for laparoscopic surgery.
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 |
|---|---|---|
| NonThis is a retrospective study, without intervention. | Other | Neoplastic group, Non-neoplastic group |
Primary outcome
Pathological diagnosis of polyps
Time frame: Up to two weeks after surgery
Pathological diagnosis of polyps
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 21 Feb 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.
Qiang Qu, Doctor study director
Peking Union Medical College Hospital
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 Polyp Gallbladder, run by Peking Union Medical College Hospital at 1 site in China.
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 21 Feb 2021. 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 China. 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?
Pathological diagnosis of polyps (time frame: Up to two weeks after surgery). 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 21 Feb 2021.