Colonic PolypNCT05189912
Clinical Study on the Application of a Specimen Retrieving Bag to Reduce the Polyp Fragmentation Rate
A study testing Specimen retrieving bag and Sucking polyps to the instrument channel port in people with Colonic Polyp, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
It is necessary to retrieve the resected polyp to determine the pathological nature of polyp and to judge the completeness of resection in polypectomy. For polyps with a larger diameter (>5mm), the most reliable way to retrieve them is to suck them out with the colonoscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Specimen retrieving bag and Sucking polyps to the instrument channel port
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2022to 14 Aug 2022
- Phase
- Interventional
- 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
Who may be able to join
- Single polyp, with a diameter of 5-15mm,
- Written informed consent.
Who cannot join
- Polyps that were not removed en bloc,
- Underlying bleeding disorder,
- The platelet count less than 50×10^9/L,
- Serious cardio-pulmonary, hepatic or renal disease,
- Intolerance to endoscopy,
- Other high-risk conditions or disease (such as massive ascites, etc.),
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Medical Center of Chinese PLA General Hosptial
Beijing, Beijing Municipality, 100039
About this study
Official title: Clinical Study on the Application of a Specimen Retrieving Bag in Endoscopic Polypectomy to Reduce the Polyp Fragmentation Rate
It is necessary to retrieve the resected polyp to determine the pathological nature of polyp and to judge the completeness of resection in polypectomy. For polyps with a larger diameter (>5mm), the most reliable way to retrieve them is to suck them out with the colonoscope. However, this method requires multiple colonoscope insertions, resulting in prolonged operation time and increased patient suffering. Therefore, clinicians often receive polyps by pressing the colonoscope suction valve. But it is difficult to receive polyps or even fail to receive. Even if the polyps were successfully received by this method, many polyps were fragmented. When the polyp is fragmented, the pathologist cannot be sure of the completeness of the polyp removal.
By removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port, the polyp fragmentation rate was reduced greatly. To further reduce the polyp fragmentation rate, while reducing the operation time and colon insertions, we applied the polyp receiving bag in colonoscopy operations. The primary purpose of this study is to evaluate the effectiveness of the application of the polyp retrieving bag to reduce the polyp fragmentation rate.
Read the detailed description
After polyp resection, it is necessary to retrieve the resected polyp to determine the pathological nature of polyp and to judge the completeness of resection in polypectomy. For polyps with a small diameter (≤5mm), usually by pressing the suction valve button of the colonoscope, polyps could be completely retrieved through a trap. For polyps with a larger diameter (>5mm), the most reliable way to retrieve them is to suck them out with the colonoscope. However, this method requires multiple colonoscope insertions, resulting in prolonged operation time and increased patient suffering. Therefore, clinicians often receive resected polyps with larger diameters by pressing the colonoscope suction valve. However, it is difficult to receive polyps or even fail to receive. Even if the polyps were successfully received, many polyps were fragmented, and the polyp fragmentation rate can be as high as 36.6%~ 60.3%. When the polyp is fragmented, the pathologist cannot be sure of the completeness of the polyp removal. Due to the possibility of malignant transformation in some polyps, the completeness of polyp resection is essential to guide the following treatment.
Some effective methods were developed to reduce polyp fragmentation, including removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port. The resulting polyp fragmentation rates are 22.4-43.0% and 18.5%, respectively. To further reduce the polyp fragmentation rate, while reducing the operation time and improving the efficiency of the operation, we applied the polyp receiving bag in colonoscopy operations. In a previous pilot study, the polyp receiving bag has been applied in clinical practice, and its polyp fragmentation rate and polyp recovery failure rate are quite low. The primary purpose of this study is to evaluate the effectiveness of the application of the Polyp retrieving bag to reduce the polyp fragmentation rate.
- Conditions
- Colonic Polyp
- Being tested
- Specimen retrieving bag, Sucking polyps to the instrument channel port
- Keywords
- Colonic Polyp, Specimen retrieval bag, Polyp fragmentation
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen retrieving bagDevice
Specimen retrieving bag was used to retrieve resected polyps.
Sucking polyps to the instrument channel portBehavioural
Remove the colonoscope suction valve and connect a polyp trap to suction onto the instrument channel port.
| Study group | Role | What they receive |
|---|---|---|
| Specimen retrieving bag group | Experimental | Resected polyps were retrieved by specimen retrieving bag. This group was set as a experimental group. Receives: Device: Specimen retrieving bag |
| Suction group | Active comparator | Resected polyps were retrieved by removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port.
This group was set as a control group. Receives: Behavioral: Sucking polyps to the instrument channel port |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp fragmentation rate
The proportion of fragmented polyps to all polyps.
Measured: 1 day
Secondary outcomes (3)
Retrieving failure rate
The proportion of polyps that failed to be retrieved to all polyps removed.
Measured: 1 day
The duration time of polyp resection
The duration time of polyp resection to the colonoscopy withdraw from body.
Measured: 1day
The insertion times of colonoscopy
The insertion times of colonoscopy during the operation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start17 Jan 2022
- Primary completion30 Jul 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, MD, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189912
- Sponsor's protocol ID
- Polyp bag frag
- Status last verified
- Mar 2024
- First submitted
- 28 Dec 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chu J, Ma C, Min M, Bi Q, Shen W, Zhang X, Zhang H, Li A, Liu Y, Lu Z. A novel polyp retrieval bag reduces the polyp fragmentation rate in colon polypectomy: a single-blind randomized controlled study. Int J Colorectal Dis. 2024 Jul 24;39(1):118. doi: 10.1007/s00384-024-04694-9.
PubMed 39048748
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Application of a Specimen Retrieving Bag in Endoscopic Polypectomy to Reduce the Polyp Fragmentation Rate
- ClinicalTrials.gov ID
- NCT05189912
- Acronym / sponsor ID
- Polyp bag frag
- Conditions
- Colonic Polyp
- Keywords
- Colonic Polyp, Specimen retrieval bag, Polyp fragmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 13 Jan 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.
It is necessary to retrieve the resected polyp to determine the pathological nature of polyp and to judge the completeness of resection in polypectomy. For polyps with a larger diameter (>5mm), the most reliable way to retrieve them is to suck them out with the colonoscope. However, this method requires multiple colonoscope insertions, resulting in prolonged operation time and increased patient suffering. Therefore, clinicians often receive polyps by pressing the colonoscope suction valve. But it is difficult to receive polyps or even fail to receive. Even if the polyps were successfully received by this method, many polyps were fragmented. When the polyp is fragmented, the pathologist cannot be sure of the completeness of the polyp removal.
By removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port, the polyp fragmentation rate was reduced greatly. To further reduce the polyp fragmentation rate, while reducing the operation time and colon insertions, we applied the polyp receiving bag in colonoscopy operations. The primary purpose of this study is to evaluate the effectiveness of the application of the polyp retrieving bag to reduce the polyp fragmentation rate.
Detailed description
After polyp resection, it is necessary to retrieve the resected polyp to determine the pathological nature of polyp and to judge the completeness of resection in polypectomy. For polyps with a small diameter (≤5mm), usually by pressing the suction valve button of the colonoscope, polyps could be completely retrieved through a trap. For polyps with a larger diameter (>5mm), the most reliable way to retrieve them is to suck them out with the colonoscope. However, this method requires multiple colonoscope insertions, resulting in prolonged operation time and increased patient suffering. Therefore, clinicians often receive resected polyps with larger diameters by pressing the colonoscope suction valve. However, it is difficult to receive polyps or even fail to receive. Even if the polyps were successfully received, many polyps were fragmented, and the polyp fragmentation rate can be as high as 36.6%~ 60.3%. When the polyp is fragmented, the pathologist cannot be sure of the completeness of the polyp removal. Due to the possibility of malignant transformation in some polyps, the completeness of polyp resection is essential to guide the following treatment.
Some effective methods were developed to reduce polyp fragmentation, including removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port. The resulting polyp fragmentation rates are 22.4-43.0% and 18.5%, respectively. To further reduce the polyp fragmentation rate, while reducing the operation time and improving the efficiency of the operation, we applied the polyp receiving bag in colonoscopy operations. In a previous pilot study, the polyp receiving bag has been applied in clinical practice, and its polyp fragmentation rate and polyp recovery failure rate are quite low. The primary purpose of this study is to evaluate the effectiveness of the application of the Polyp retrieving bag to reduce the polyp fragmentation rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specimen retrieving bag group | Experimental | Device: Specimen retrieving bagResected polyps were retrieved by specimen retrieving bag. This group was set as a experimental group. |
| Suction group | Active comparator | Behavioral: Sucking polyps to the instrument channel portResected polyps were retrieved by removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port. This group was set as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single polyp, with a diameter of 5-15mm,
- Written informed consent.
Key exclusion criteria (7 listed)
- Polyps that were not removed en bloc,
- Underlying bleeding disorder,
- The platelet count less than 50×10^9/L,
- Serious cardio-pulmonary, hepatic or renal disease,
- Intolerance to endoscopy,
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 |
|---|---|---|
| Specimen retrieving bagSpecimen retrieving bag was used to retrieve resected polyps. | Device | Specimen retrieving bag group |
| Sucking polyps to the instrument channel portRemove the colonoscope suction valve and connect a polyp trap to suction onto the instrument channel port. | Behavioural | Suction group |
Primary outcome
Polyp fragmentation rate
Time frame: 1 day
The proportion of fragmented polyps to all polyps.
3 secondary outcomes
Retrieving failure rate
Time frame: 1 day
The duration time of polyp resection
Time frame: 1day
The insertion times of colonoscopy
Time frame: 1 day
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 2 Apr 2024.
- Derived from this study: PubMed 39048748Chu J, Ma C, Min M, Bi Q, Shen W, Zhang X, Zhang H, Li A, Liu Y, Lu Z. A novel polyp retrieval bag reduces the polyp fragmentation rate in colon polypectomy: a single-blind randomized controlled study. Int J Colorectal Dis. 2024 Jul 24;39(1):118. doi: 10.1007/s00384-024-04694-9.
- Individual participant dataSharing planned: No
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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.
Yan Liu, MD principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specimen retrieving bag and Sucking polyps to the instrument channel port in people with Colonic Polyp, run by Affiliated Hospital to Academy of Military Medical Sciences 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 2 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 2 Apr 2024. 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?
Polyp fragmentation rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05189912, which also lists 1 linked publication.
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 2 Apr 2024.