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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyp
• Intervention / Treatment: Device: Specimen retrieving bag; Behavioral: Sucking polyps to the instrument channel port

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 Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Liu, MD; Phone Number: +8613911798288; Email: 13911798288@163.com
• Study Contact Backup: Name: Jin Dong Chu, MD; Phone Number: +8615811201126; Email: chu465292278@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • The Fifth Medical Center of Chinese PLA General Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specimen retrieving bag group; Resected polyps were retrieved by specimen retrieving bag. This group was set as a experimental group.	Device: Specimen retrieving bag; Specimen retrieving bag was used to retrieve resected polyps.
Active Comparator: Suction group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp fragmentation rate	The proportion of fragmented polyps to all polyps.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrieving failure rate	The proportion of polyps that failed to be retrieved to all polyps removed.	1 day
The duration time of polyp resection	The duration time of polyp resection to the colonoscopy withdraw from body.	1day
The insertion times of colonoscopy	The insertion times of colonoscopy during the operation.	1 day

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yan Liu, MD, Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): August 14, 2022

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Colonic Polyp; Specimen retrieval bag; Polyp fragmentation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: Polyp bag frag

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No