A Novel Polyp Retrieval Bag Reduces the Polyp Fragmentation Rate in Colon Polypectomy : A Single-Blind Randomized Controlled Study

doi:10.21203/rs.3.rs-4341366/v1

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A Novel Polyp Retrieval Bag Reduces the Polyp Fragmentation Rate in Colon Polypectomy : A Single-Blind Randomized Controlled Study

https://doi.org/10.21203/rs.3.rs-4341366/v1

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Journal Publication

published 24 Jul, 2024

Read the published version in International Journal of Colorectal Disease →

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Purpose

The fragmentation of polyps affects complete resection confirmation. The primary aim of this study was to assess the feasibility of a novel polyp retrieval bag for reducing the fragmentation rate of colon polyps.

Methods

Patients with a 5–15 mm colon polyp were recruited and randomized to two groups at a 1:1 ratio. After polyp resection, polyps obtained from patients in the treatment group were extracted using a novel polyp retrieval bag without traversing the instrument channel, while polyps obtained from patients in the control group were collected by traversing the instrument channel, attaching the polyp trap to the instrument channel port and applying suction.

Results

From January to July, 2022, a total of 225 patients were assessed for study eligibility. A total of 204 patients were enrolled in the study, and seven patients with specimen retrieval failure were excluded from the analysis. The polyp fragmentation rate in the treatment group was significantly lower than that in the control group (3.0% [3/100] vs. 17.5% [17/97], P = 0.001). There was no significant difference in the retrieval failure rates between the treatment group and control group (2.0% [2/102] vs. 4.9% [5/102], P = 0.442). There were fewer colonoscope insertions in the treatment group than in the control group (102 vs. 110), but a significant difference was not present (P = 0.065). No significant adverse events were observed in the follow-up.

Conclusions

This study demonstrated that the polyp retrieval bag was safe and feasible for reducing the fragmentation rate of retrieved polyps.

Trial registration:

The study was registered at ClinicalTrials.gov ( NCT05189912, 1/12/2021).

colonic polyps

colonoscopy

polyp retrieval

fragmentation

The resected polyp must be retrieved for histopathological diagnosis and complete resection confirmation after polyp resection[1]. Depending on the size of polyps, they may be retrieved via aspiration through the channel of a colonoscope or by means of direct removal with a colonoscope without traversing the channel. In most cases, small polyps that are 15 mm or less in diameter can be aspirated through the channel of a colonoscope, and the related methods include the conventional method of pressing the suction valve button and retrieving the polyp, removing the suction valve and covering the open suction valve cylinder with a finger, using a Roth Net polyp retriever placed through the instrument channel, and connecting a polyp trap to suction onto the instrument channel port[2] .Large polyps that are > 15 mm can be recaptured by polyp retriever nets or other devices, such as small grip-seal plastic bags[3] and polypectomy snares[4], and can be recovered by withdrawal of the colonoscope.

However, previous reports showed that many retrieved polyps traversing the channel of a colonoscope were fragmented, and the polyp fragmentation rate could be as high as 18.5%~ 60.3%[2, 5]. This serious issue makes it difficult for the pathologist to accurately determine the completeness of the resection and the submucosal invasion[6].

To more efficiently retrieve resected polyps and reduce polyp fragmentation, we designed a self-expanding polyp retrieval bag. The polyp retrieval bag has the capability to retrieve one or more polyps, and they do not traverse the biopsy channel after polyp retrieval, thereby reducing the rate of polyp fragmentation. The method selected for control in this study was the one documented in the literature with the lowest polyp fragmentation rate transversing instrument channels, which is removing the polyp through the instrument channel by connecting the polyp trap to the instrument port[2] .The aim of this study was to assess the fragmentation of polyps extracted using the above two methods.

Patients

This study was a single-center randomized controlled clinical trial that involved patients undergoing colonic polypectomy. We included adults aged at least 18 years with a colonic polyp sized 5–15 mm. The exclusion criteria were as follows: polyps that were not removed en bloc; underlying bleeding disorder; platelet count less than 50×10^9/L; serious cardiopulmonary, hepatic, or renal disease; intolerance to endoscopy; other high-risk conditions or diseases (such as massive ascites); and pregnancy. This study was approved by the institutional review board of the Fifth Medical Center of PLA General Hospital and was performed in accordance with the Declaration of Helsinki. Written informed consent was acquired from all enrolled patients. The study was registered at ClinicalTrials.gov ( NCT05189912, 1/12/2021). Demographic and clinical data, including patient age, sex, quality of bowel preparation, pathological diagnosis, polyp size, location, morphology, resection methods, and retrieval failures, were collected for all patients.

Randomization and masking

Eligible patients were randomized to two groups in a 1:1 ratio using a computer-generated list of random numbers. If the patient had multiple eligible polyps, only the first eligible polyp detected was selected for examination. A numbered opaque sealed envelope was used for randomization. Patients were blinded to randomization. Two endoscopists performed polyp resection and retrieval. Polyps were resected using cold snare or endoscopic submucosal resection (EMR) according to the endoscopists’ experience. After polyp resection, patients were followed up for 14 days to observe if any adverse events occurred.

Methods of polyp retrieval

Polyps in the two groups were retrieved by two methods. The treatment group utilized a polyp retrieval bag made of a self-expanding stone extraction basket (SEB-A-30/55 − 7/200, Micro-Tech, Nanjing, China) covered with a plastic film, with an expansion size of 5.5 cm×3.0 cm (length×width) (Fig. 1). After polyp resection, the closed bag was delivered through the instrument channel by a plastic cannula, and the bag opened automatically after placement in the colon. The resected polyps were then placed into the bag by using a hemostatic clip (ROCC-D-26-195, Micro-Tech, Nanjing, China) or biopsy forceps (LMFB-23-180-III, Lookmed, Changzhou, China) (Fig. 2a). After the procedure was concluded, the metal top of the polyp retrieval bag was grasped by a polypectomy snare (X-20, MTW-Endoscopie, Sebastian, Germany) and pulled close to the colonoscope. The opening of the bag was shrunken (Fig. 2b) before it was pulled out of the colon with a colonoscope (EC-600 WM, Fujifilm Co, Tokyo, Japan). The control group involved connecting a polyp trap (e-Linkcare Meditech Co, Hangzhou, China) onto the instrument channel port with suction applied[2]. The rationale for choosing the method in the control group is that it has the lowest fragmentation rate among the four methods in previous studies[2].

Assessment of polyp fragmentation

According to Barge W et al[2] and Kishida Y et al[5], polyp fragmentation is defined as the presence of multiple pieces in the gross description of the specimen in formalin. Two experienced pathologists reviewed the specimens independently, and they were not informed about the patient randomization. Polyps were reviewed for fragmentation less than two hours after removal.

Primary and secondary outcomes

The primary outcome of this study was the polyp fragmentation rate in the two groups. Polyp retrieval failure rates, colonoscope insertions and adverse events, including postpolypectomy syndrome, delayed bleeding and delayed perforation, were the secondary outcomes. Polyp retrieval failure is defined as failing to retrieve a polyp by the allocated retrieval method or missing the resected polyps. If a polyp was missed or could not be retrieved by the allocating method, it was excluded from the analysis, retrieved by an alternative technique and withdrawn by using the colonoscope or aspiration through the suction channel of the colonoscope.

Statistical analysis

The sample size calculation utilized the t test for two independent samples and was based on the primary outcome measure of decreasing the polyp fragmentation rate. According to the design principles, the polyp fragmentation rate of treatment group was lower than 1%, whereas the lowest polyp fragmentation rate for control group has been reported as 18.5%[2]. To detect a difference with 80% power (assuming a two-sided significance level of 5%), the study required 43 patients in each group (86 patients in total). To account for a retrieval failure rate of 10%−15%, as previously reported[7], the recruitment target was increased to 102 patients (51 patients in each group).

The researchers voiced concerns about a relatively low fragmentation rate in the control group, and an interim analysis of the study was conducted after 74 patients had been recruited. A new target sample size was increased to 196 patients to reduce the fragmentation rate from 12.0% (the control group) to 2.5% (the treatment group). The study was stopped once the sample size reached 204 patients. The sample size calculation was performed using SAS 9.4.

Categorical variables are presented as frequencies and percentages and were compared using χ2 tests, Fisher's exact tests or continuous correction χ2 tests. Continuous variables are presented as the mean and standard deviation (SD) and were compared using independent t tests. The P values obtained were two-sided, and a P value of < 0.05 was considered significant in all cases. Statistical analyses were carried out using SPSS version 26. To analyze risk factors, logistic regression analysis was applied for multivariate regression analysis. Statistical analysis was performed by R statistics version 3.5.3.

Patients

From January 17, 2022 to July 30, 2022, a total of 225 patients were assessed for study eligibility. A total of 204 patients with eligible colonic polyps were enrolled in this study, and seven patients with polyp retrieval failure were excluded from the analysis. Ultimately, 97 patients in the control group and 100 patients in the treatment group were included in the final analysis (Fig. 3). The baseline characteristics of the patients and polyps are shown in Table 1. There were no significant differences between the patient characteristics or the polyp features between the two groups.

Table 1

Characteristics of patients and polyps
	Control group	Treatment group	P value
	Polyp trap attached to instrument channel port n = 97	Polyp retrieved bag n = 100	P value
Sex, n (%)			0.769
Male	68 (70.1)	72 (72.0)
Female	29 (29.9)	28 (28.0)
Age, y, mean (SD)	60.2 (10.2)	60.4 (10.9)	0.919
Polyp location, n (%)			0.076
Proximal*	46 (47.4)	35 (35.0)
Distal	51 (53.6)	65 (65.0)
Size, n (%)			0.630
5−9mm	46 (47.4)	44 (44.0)
10−15mm	51 (52.6)	56 (56.0)
Morphology, n (%)			0.897
Flat	22 (22.7)	26 (26.0)
Sessile	67 (69.1)	66 (66.0)
Pedunculated	8 (8.2)	8 (8.0)
Pathology, n (%)			0.195
Tubular adenoma	65 (67.0)	78 (78.0)
Tubulovillous adenoma	3 (3.1)	4 (4.0)
Hyperplastic	28 (28.9)	17 (17.0)
Serrated adenoma	1 (1.0)	1 (1.0)
Quality of bowel preparation, n (%)			0.780
Excellent	65 (67.0)	72 (72.0)
Good	23 (23.7)	20 (20.0)
Fair	9 (9.3)	8 (8.0)
Resection method, n (%)			0.500
EMR	73 (75.3)	71 (71.0)
Cold snare	24 (24.7)	29 (29.0)
Endoscopist, n (%)			0.518
A	52 (53.6)	49 (49.0)
B	45 (46.4)	51 (51.0)
Fragmentation rates, n (%)	17 (17.5)	3 (3.0)	0.001
Retrieving failure rates, %	4.9 (5/102)	2 .0 (2/102)	0.442
Colonoscope insertions, n	110	102	0.065
1 insertion	95	101
2 insertions	6	1
3 insertions	1	0
SD, Standard Deviation; EMR, Endoscopic Submucosal Resection; *Including Cecum, ascending colon and hepatic flexture.

Primary outcome

The fragmentation rate of the treatment group was significantly lower than that of the control group (3.0% [3/100] vs. 17.5% [17/97], P = 0.001) (Table 1). In both groups, the polyp location, polyp size, polyp morphology, polyp pathology, resection methods, and endoscopists did not have a significant impact on the fragmentation rates (Table 2). When analyzing the fragmentation rates in the two groups based on differences in bowel preparation quality, there was no significant difference in fragmentation rates within the control group (18.5% [12/65, excellent] vs. 13.0% [3/23, good] vs. 22.2% [2/9, fair]), P = 0.699). However, there was a significant difference in the fragmentation rates that was dependent on bowel preparation quality, as the rates of fragmentation were 1.4% (1/72, excellent), 0% (0/20, good), and 25.0% (2/8, fair) (P = 0.033). However, considering that only three polyps were fragmented in the treatment group, the applicability of this finding was limited. The interobserver concordance of polyp macroscopic fragmentation between the two pathologists was 100%.

Table 2

Fragmentation rates of two poly retrieval methods
	Fragmentation rate (%)
	Control group	P value	Treatment group	P value
	Polyp trap attached to instrument channel port		Polyp retrieved bag
Total polyps	17.5 (17/97)		3.0 (3/100)
Polyp location		0.270		> 0.999
Proximal*	13.0 (6/46)		2.9 (1/35)
Distal	21.6 (11/51)		3.1 (2/65)
Size		0.570		> 0.999
5-9mm	15.2 (7/46)		0 (0/44)
10-15mm	19.6 (10/51)		5.4 (3/56)
Morphology		0.426		0.655
Flat	22.7 (5/22)		0 (0/26)
Sessile	17.9 (12/67)		4.5 (3/63)
Pedunculated	0 (0/8)		0 (0/8)
Pathology		0.647		> 0.999
Tubular adenoma	18.5 (12/66)		3.8 (3/78)
Tubulovillous adenoma	33.3 (1/3)		0 (0/4)
Hyperplastic	14.3 (4/28)		0 (0/17)
Serrated adenoma	0 (0/1)		0 (0/1)
Quality of bowel preparation		0.699		0.033
Excellent	18.5 (12/65)		1.4 (1/72)
Good	13.0 (3/23)		0 (0/20)
Fair	22.2 (2/9)		25.0 (2/8)
Resection method		0.455		0.554
EMR	19.2 (14/73)		4.2 (3/71)
Cold snare	12.5 (3/24)		0 (0/29)
Endoscopist		0.551		0.972
A	15.4 (8/52)		4.1 (2/49)
B	20.0 (9/45)		2.0 (1/51)
EMR, Endoscopic Submucosal Resection; *Including Cecum, ascending colon and hepatic flexture.

The logistic analysis of the fragmentation rate in the control group did not identify risk factors (including sex, age, polyp location, quality of bowel preparation, polyp size, morphology, pathology, resection method and different endoscopists) that could have affected the outcome of fragmentation (Table 3).

Table 3

Relationship of each factor with polyp fragmentation in the control group (univariate analysis)
Characteristics		Polyps fragment/intact (n) (17/80)	OR (95% CI)	P value
Sex	Male	11/57	Reference
	Female	6/23	1.35 (0.45–4.09)	0.593
Age, y, mean(SD)		61.2 (7.7) /60.1 (10.6)	1.01 (0.96–1.07)	0.677
Polyp location	Proximal*	6/40	Reference
	Distal	11/40	1.36 (0.47–3.93)	0.571
Quality of bowel preparation	Excellent	12/53	0.79 (0.15–4.30)	0.788
Quality of bowel preparation	Adequate	3/20	0.53 (0.07–3.82)	0.525
	Inadequate	2/7	Reference
Size	5-9mm	7/39	Reference
	10-15mm	10/41	1.36 (0.47–3.93)	0.571
Morphology	Flat	5/17	Reference
	Sessile	12/55	0.74 (0.23–2.41)	0.619
	Pedunculated	0/8	< 0.01 (0-infinite)	0.991
Pathology	Tubular adenoma	12/54	Reference
	Tubulovillous adenoma	1/2	2.21 (0.18–26.39)	0.531
	Hyperplastic	4/24	0.74 (0.22–2.52)	0.625
	Serrated adenoma	0/1	< 0.01 (0-infinite)	0.992
Resection method	EMR	14/59	1.66 (0.43–6.36)	0.459
	Cold snare	3/21	Reference
Endoscopist	A	8/44	Reference
	B	9/36	1.38 (0.48–3.93)	0.552
EMR, Endoscopic Submucosal Resection; *Including Cecum, ascending colon and hepatic flexture.

Secondary outcomes

Five polyps were hard to retrieve by suctioning them into the polyp trap through the instrument channel port, which were deemed retrieval failures, but they were captured within a polypectomy snare and recovered by withdrawal of the colonoscope. One polyp sized 5 mm was difficult to drop into the polyp retrieval bag and was recovered by biopsy forceps. One polyp sized 5 mm and allocated to the treatment group was missed before being placed into the polyp retrieval bag. There was no significant difference in the retrieval failure rates between the treatment group and control group (2.0% [2/102] vs. 4.9% [5/102], P = 0.442) (Table 1). Although there were fewer colonoscope insertions in the treatment group than in the control group (102 vs. 110), a significant difference was not present (P = 0.065) (Table 1). No significant adverse events, such as postpolypectomy syndrome, delayed bleeding or delayed perforation, were observed during the follow-up in either group.

Because of the risk of developing colorectal cancer, colonoscopic removal of precancerous polyps is recommended[8]. However, incompletely resected polyps have been an important issue clinically and have been implicated in the development of interval colorectal cancer[9, 10], which has a significantly increased risk of death[11] .Meanwhile, fragmentation of polyps is common during specimen retrieval. The reported polyp fragmentation rate for polyps with a size of 5–15 mm by the conventional retrieval method, which involves aspiration through the suction channel of the colonoscope, is as high as 18.5%~60.3%[2, 5]. This high fragmentation rate influences evaluation by pathologists for the completeness of resected polyps; furthermore, it may affect the subsequent treatment for patients. Thus, a reliable polyp retrieval method with a low polyp fragmentation rate is needed.

Some simple but effective methods have been developed to reduce polyp fragmentation, including removing the suction valve and connecting a polyp trap to suction onto the instrument channel port. The reported polyp fragmentation rates for these methods are 22.4–43.0% and 18.5%[2, 5], respectively. The water-slider method involves surrounding polyps with water from an auxiliary water channel during suctioning, and the polyp fragmentation rate for this method has been reported as 8.2%[12]. However, the polyps included in this study were smaller (≤ 10 mm in size). Other methods involve extra devices, including grip-seal plastic bags[3] and the Roth retrieval net[4]. However, no data have been reported on the polyp fragmentation rate for grip-sealed plastic bags and retrieval nets.

The retrieved polyps will be not fragmented if they are not retrieved through a colonoscope channel, but no data have been reported. We invented and applied the polyp retrieval bag in polypectomy; this was modeled after the success of the specimen retrieval bag in laparoscopic appendectomy[13, 14]. Unlike other methods, the polyp retrieval bag cannot pass through the colonoscope channel after polyp retrieva. The polyp retrieval bag is designed with a large volume, small opening, and insulation, which allows for easy manipulation. The plastic film is used for insulation to avoid electrical injury, the self-expanding metal basket is used to avoid folding of the plastic film and is convenient for delivery in the instrument channel, and the fusiform designation ensures a large volume and small opening. Moreover, since the long axis of the expanding polyp retrieval bag is parallel to the colonic lumen, it is easy to place resected polyps into the bag with hemostatic clips or biopsy forceps. Thus, the operability of the polyp retrieval bag is superior to that of the retrieval net. Owing to these advantages, the polyp retrieval bag is suitable for retrieving polyps with large sizes, multiple polyps, and specimens of piecemeal endoscopic mucosal resection, thus avoiding repeated colonoscope insertions.

This size of polyp was chosen in this study because it can easily be suctioned through the colonoscopy instrumental channel, which was related to the control method. Through the colonoscopy instrumental channel, polyps that are smaller than 5 mm can easily be removed and retrieved with biopsy forceps, while polyps that are larger than 15 mm are difficult to remove with suction. In this study, the polyp fragmentation rate in the treatment group was significantly lower than that in the control group. Nevertheless, three polyps in the treatment group were fragmented after retrieval. At least two potential explanations exist to explain this. First, the utilization of forceps or clips to secure polyps results in their destruction. Second, the anal sphincter crushed polyps in the bag. In addition, one polyp retrieval failure in the treatment group was recorded in this study, and it was more difficult to retrieve small polyps. Dropping polyps after opening the forceps relies on gravity; therefore, it was easy to drop large polyps. However, small polyps were prone to adhere to the biopsy forceps, which made it difficult to drop them into the bag. This is one of the limitations of the polyp retrieval bag. Another limitation is that the opening size of the bag is limited, and polyps with a hard texture or polyps that are ≥ 2 cm may not be suitable for retrieval. Therefore, the polyp retrieval bag is suitable for retrieving polyps sized 5–20 mm. Moreover, the manipulation of the polyp retrieval bag is more complex than the conventional method.

We also acknowledge several limitations in our study. One limitation of this study was that the single blind design may affect patients’ selection;Another limitation was that the size of polyps included in this study was between 5 and 15 mm, and polyps outside this size range were not studied. Additionally, the recovery of polyps involved several devices, such as forceps/clips and snares, which resulted in a complicated course of retrieval. Also, this study cannot answer whether it is better to retrieve polyps after resecting them all or to retrieve them while resecting for patients with multiple polyps. These issues should be explored in future research.

In conclusion, in this single-center randomized controlled study, we demonstrated that the polyp retrieval bag was effective for polyp retrieval, and it greatly decreased the fragmentation rate of polyps. Future studies should explore its ability o reduce the number of colonoscope insertions in patients with multiple and large (> 15 mm) polyps.

Acknowledgments

We express our deep gratitude to Dr. Jiazi Liu and Dr. Xueli Zhang in the Department of Pathology at the Fifth Medical center of Chinese PLA General Hospital for their kind support for pathology diagnosis.

Funding

This study was supported by grants from National Natural Science Foundation of China (No. 82270694), National Natural Science Foundation of China (No. 82170677), and Outstanding Youth Training Fund of the Chinese PLA General Hospital (No. 2019-JQPY-001).

Ethics approval and consent to participate:

This study followed the Declaration of Helsinki and has been approved by the Institutional Review Board of the Fifth Medical Center of PLA General Hospital (approval no. KY202112302) . Written consent form will be obtained from all patients. All patients will be informed of the details of the study (objective, procedure, and potential risks) in written form, and the informed consent will be signed before the allocation.

Consent for publication:

Written informed consent to publish the clinical details and images of the patient was obtained.

Conflict of interest

The authors declare no competing interests.

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No competing interests reported.

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published 24 Jul, 2024

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You are reading this latest preprint version

A Novel Polyp Retrieval Bag Reduces the Polyp Fragmentation Rate in Colon Polypectomy : A Single-Blind Randomized Controlled Study

Status:

Journal Publication

Version 1

Abstract

Purpose

Methods

Results

Conclusions

Trial registration:

Figures

Introduction

Methods

Patients

Randomization and masking

Methods of polyp retrieval

Assessment of polyp fragmentation

Primary and secondary outcomes

Statistical analysis

Results

Patients

Primary outcome

Secondary outcomes

Discussion

Conclusions

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1