Clinical Study on the Application of a Specimen Retrieving Bag to Reduce the Polyp Fragmentation Rate

Colonic Polyp Clinical Trial

Official title:

Clinical Study on the Application of a Specimen Retrieving Bag in Endoscopic Polypectomy to Reduce the Polyp Fragmentation Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05189912
• Other study ID #: Polyp bag frag
• Status: Completed
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: August 14, 2022

Study information

• Verified date: March 2024
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: August 14, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Single polyp, with a diameter of 5-15mm,

2. Written informed consent.

Exclusion Criteria:

1. Polyps that were not removed en bloc,

2. Underlying bleeding disorder,

3. The platelet count less than 50×10^9/L,

4. Serious cardio-pulmonary, hepatic or renal disease,

5. Intolerance to endoscopy,

6. Other high-risk conditions or disease (such as massive ascites, etc.),

7. Pregnancy.

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Device:
• Specimen retrieving bag
Specimen retrieving bag was used to retrieve resected polyps.

Behavioral:
• Sucking polyps to the instrument channel port
Remove the colonoscope suction valve and connect a polyp trap to suction onto the instrument channel port.

Locations

Country	Name	City	State
China	The Fifth Medical Center of Chinese PLA General Hosptial	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyp fragmentation rate	The proportion of fragmented polyps to all polyps.	1 day
Secondary	Retrieving failure rate	The proportion of polyps that failed to be retrieved to all polyps removed.	1 day
Secondary	The duration time of polyp resection	The duration time of polyp resection to the colonoscopy withdraw from body.	1day
Secondary	The insertion times of colonoscopy	The insertion times of colonoscopy during the operation.	1 day