Retrospective Cohort Study Open Access
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jan 16, 2025; 17(1): 97840
Published online Jan 16, 2025. doi: 10.4253/wjge.v17.i1.97840
Outcomes of bile duct cannulation using a novel contrast-enhanced catheter: A single-center, retrospective cohort study
Toru Kaneko, Mitsuhiro Kida, Takahiro Kurosu, Gen Kitahara, Shiori Koyama, Nao Nomura, Kumiko Tahara, Department of Gastroenterology, Kitasato University Medical Center, Kitamoto 364-8501, Saitama, Japan
Chika Kusano, Department of Gastroenterology, Kitasato University Hospital, Sagamihara 252-0375, Kanagawa, Japan
ORCID number: Toru Kaneko (0000-0003-1924-1755); Mitsuhiro Kida (0000-0002-5794-1130); Takahiro Kurosu (0000-0003-4639-4001); Gen Kitahara (0009-0003-1453-0125); Shiori Koyama (0009-0006-7640-9912); Nao Nomura (0009-0002-1271-5831); Kumiko Tahara (0000-0002-6417-1322); Chika Kusano (0000-0002-3789-4787).
Author contributions: Kaneko T conceptualized the study, carried out data collation, conducted formal analysis and surveys, was responsible for methodology, project management, validation and visualization, and participated in writing the original manuscript; Kurosu T, Kitahara G, Koyama S, Nomura N, and Tahara K were responsible for the resources; Kida M and Kusano C supervised the study; Kaneko T, Kida M, Kurosu T, Kitahara G, Koyama S, and Kusano C were involved in writing review and editing; and all authors have read and approved the final manuscript.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Kitasato University Medical Center in Japan, approval No. 2023011.
Informed consent statement: All participants provided written informed consent before the procedure.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Toru Kaneko, MD, PhD, Department of Gastroenterology, Kitasato University Medical Center, 6-100 Arai, Kitamoto 364-8501, Saitama, Japan. toru5646@gmail.com
Received: June 14, 2024
Revised: December 19, 2024
Accepted: January 2, 2025
Published online: January 16, 2025
Processing time: 215 Days and 17.8 Hours

Abstract
BACKGROUND

Endoscopic retrograde cholangiopancreatography is a challenging procedure involving bile duct cannulation. Despite the development of several cannulation devices, none have effectively facilitated the procedure.

AIM

To evaluate the efficacy of a recently developed catheter for bile duct cannulation.

METHODS

We retrospectively examined 342 patients who underwent initial cholangiopancreatography. We compared the success rate of bile duct cannulation and the incidence of complications between the groups using existing and novel catheters.

RESULTS

The overall success rates of bile duct cannulation were 98.3% and 99.1% in the existing and novel catheter groups, respectively (P = 0.47). The bile duct cannulation rate using the standard technique was 73.0% and 82.1% in the existing and novel catheter groups, respectively (P = 0.042). Furthermore, when catheterization was performed by expert physicians, the bile duct cannulation rate was significantly higher in the novel catheter group (81.3%) than in the existing catheter group (65.2%) (P = 0.017). The incidence of difficult cannulation was also significantly lower in the novel catheter group (17.4%) than in the existing catheter group (33.0%) (P = 0.019).

CONCLUSION

The novel catheter improved the bile duct cannulation rate using the standard technique and reduced the frequency of difficult cannulation cases, valuable tool in endoscopic retrograde cholangiopancreatography procedures performed by experts.

Key Words: Endoscopic retrograde cholangiopancreatography; Bile duct; Cannulation; Catheter; Retrospective study

Core Tip: The use of a novel contrast-enhanced catheter improved the bile duct cannulation rate when using the standard technique and reduced the frequency of cases with difficult cannulation. These advantages were particularly notable in procedures performed by experts. Further, its application by experts has shown promise in reducing the frequency of difficult cannulation, underscoring its utility in clinical practice.



INTRODUCTION

Endoscopic retrograde cholangiopancreatography (ERCP) is useful for diagnosing and treating conditions affecting the biliopancreatic region[1-3]. ERCP is commonly used to manage diseases such as choledocholithiasis, obstructive jaundice, pancreaticobiliary malignancies, chronic pancreatitis, and biliary strictures. ERCP enables visualization of the biliary and pancreatic ducts and offers avenues for therapeutic interventions such as stone removal, stent placement, and tissue sampling for pathological examination. Notably, ERCP is a complex procedure involving several techniques, with selective bile duct cannulation being the initial and often challenging step. Selective bile duct cannulation is the first fundamental procedure to access the bile duct during ERCP. However, even experts can find it difficult to perform this procedure in some cases, with reports indicating a failure rate of approximately 5%-20% for selective bile duct cannulation in patients with a first papilla[4-7]. Difficulties in selective bile duct cannulation have been reported due to variations in patient anatomy, such as a parapapillary diverticulum or a specific papilla morphology[8-10] as well as differences in endoscopist skills[8-11]. Watanabe et al[10] focused on oral protrusion and difficulty in bile duct cannulation and reported that large oral protrusion papillae with large oral ridges are the most difficult to intubate and are the most likely causes of bile duct cannulation difficulties. Moreover, others have reported that the success rate of ERCP and the frequency of incidents are correlated with differences in endoscopists’ experience and skills and the number of experienced endoscopists at a facility[11].

Various methods and devices have been developed to improve success rates of bile duct cannulation. The conventional contrast-guided cannulation has been widely used; however, in 1987, Siegel et al[12] reported the wire-guided cannulation (WGC) method using a guidewire (GW), which has now gained broad adoption in routine practice. In some cases, bile duct cannulation is difficult using only these standard methods. Therefore, various methods have been devised for such cases, including pre-cutting[13], the double- GW technique with a GW placed in the pancreatic duct[14], two devices in one-channel method[15], endoscopic ultrasound (EUS)-guided rendezvous technique[16], and various other bile duct cannulation methods.

Approximately 10% of patients undergoing ERCP experience incidental complications[17]. Post-ERCP pancreatitis (PEP) is the most fatal incidental complication of ERCP[18]. Repeated cannulation attempts increase the risk for PEP[19]. These findings underscore the importance of facilitating bile duct cannulation to improve its success rate and reduce accidental injuries such as PEP. Recently, a novel type of catheter for cholangiography has been introduced to the market. The catheter is soft and has a chamfered tip, which allows cannulation of the bile duct without stress on the bile duct and may facilitate the procedure. A previous study comparing sphincterotomes and contrast-enhanced catheters reported that WGC with sphincterotomes had a higher rate of selective bile duct cannulation and smaller incidence of PEP[20], whereas others reported that the rate of selective bile duct cannulation and the incidence of PEP was the same[21]. However, to the best of our knowledge, no study using the new catheter has been conducted. Therefore, this study aimed to retrospectively evaluate the effects of the new cholangiographic catheter on cannulation, providing insights into its potential to improve procedural outcomes.

MATERIALS AND METHODS
Study design

This single-center, retrospective cohort study was conducted at Kitasato University Medical Center in Japan. The study was performed in accordance with the Declaration of Helsinki and approved by our hospital’s Institutional Review Board, approval No. 2023011. All participants provided written informed consent before the procedure.

Target patients

We retrospectively reviewed the medical records of patients who underwent ERCP at Kitasato University Medical Center from April 2020 to September 2023. During the specified period, 914 patients underwent ERCP, and those who met the inclusion criteria and none of the exclusion criteria were enrolled. The inclusion criteria were as follows: (1) History of ERCP for bile duct cannulation; and (2) Initial untreated papilla (naive papilla). The exclusion criteria were as follows: (1) History of ERCP for pancreatic diseases; (2) History of upper gastrointestinal surgery except the Billroth1 procedure; and (3) Duodenal stenosis that prevented endoscopic insertion to the duodenal papilla. Finally, a total of 342 patients fulfilled these criteria (Figure 1).

Figure 1
Figure 1 Study flowchart. ERCP: Endoscopic retrograde cholangiopancreatography; EUS: Endoscopic ultrasound; EUS-HGS: Endoscopic ultrasound-guided hepaticogastrostomy; EUS-rendezvous: Endoscopic ultrasound-guided rendezvous technique.
Study protocol (Figure 1)

From April 2020 to July 2022, an existing catheter (MTW ERCP catheter; MTW Endoscopy, Wesel, Germany) was used, and from August 2022 to September 2023, a novel catheter (FineJet Cannula; Gadelius Medical, Tokyo, Japan Gadelius Medical Co. Ltd., Tokyo, Japan) was used for ERCP. Of the 342 patients with untreated papillae, 230 were treated with the existing catheter, and 112 were treated using the novel catheter.

Novel catheter

The novel catheter is a disposable contrast-enhanced catheter with a 4.4 French tapered and chamfered tip (Figure 2A). The shaft diameter is 7 French and total length is 220 cm, with a central lumen accommodating up to 0.035 inches of GW and contrast medium (Figure 2B). This configuration allowed simultaneous GW operation while contrast medium flows through the lumen. The catheter has a soft overall structure owing to its large central lumen.

Figure 2
Figure 2 Novel catheter. A: The tip of the catheter is tapered and chamfered; B: Overall view.
Definition

Bile duct cannulation using only a contrast-enhanced catheter or WGC was defined as the standard technique, whereas cases wherein the catheter was changed to a sphincterotome (Clever Cut 3V; Olympus Medical Systems, Tokyo, Japan), pancreatic duct GW technique, or pre-cut two devices in one channel technique were defined as rescue techniques. Successful bile duct cannulation was defined as successful insertion of the catheter into the bile duct and successful cholangiography. Difficulty in bile duct cannulation was defined as five or more (> 5) attempts at bile duct cannulation. The procedure time was defined as the time from endoscope insertion to removal, and the bile duct cannulation time was defined as the time from the frontal view of the duodenal papillae to successful bile duct cannulation. Experts were defined as those with experience of performing > 500 ERCP procedures. When a trainee performs ERCP, the expert performs it together with the trainee as a caregiver in a supervisory position. large oral protrusion was defined as the length of the oral protuberance that was at least twice the lateral diameter of the duodenal papilla[15]. Adverse events (AE) severity was classified according to the lexicon of the American Society of Gastrointestinal Endoscopy[22].

Endpoint

The primary endpoint was the success rate of bile duct cannulation using only contrast-enhanced catheters. The secondary endpoints included the overall rate of bile duct cannulation, frequency of difficult cannulation cases, and incidence of AE.

ERCP procedure

Pethidine hydrochloride and midazolam were used for sedation. A duodenoscope (TJF290V, TJF260V, or JF260V; Olympus Medical Systems, Tokyo, Japan) was inserted into the duodenal papilla. The opening of the duodenal papillae was viewed in the frontal plane, and the bile duct was intubated with a GW (Visiglide2; Olympus Medical Systems, Filder25; Asahi Intech, Aichi, Japan) inserted into a contrast-enhanced catheter. Bile duct cannulation was initially performed using contrast-enhanced or conventional WGC. When bile duct cannulation was difficult, a rescue method was used, and the surgeon decided which method to use. Pre-cutting was performed via freehand fistulotomy using a Needle Knife (Needle Cut 3V; Olympus Medical Systems). After bile duct cannulation, endoscopic sphincterotomy, endoscopic lithectomy, or endoscopic biliary drainage was performed according to the case requirements. When a trainee performed ERCP and had difficulty intubating the bile duct, an expert replaced them after at least 10 minutes or ≥ 5-10 attempts.

Statistical analysis

According to a previous report[23], the success rate of bile duct cannulation using the conventional method is 62.8%. Assuming that the success rate improves to 80% when using a novel catheter, with an alpha error of 5% and a power of 80%, the required sample size for each group was calculated to be 105. Considering ineligible patients, we planned to include 112 patients in the novel catheter group. However, the existing catheter group had a significantly larger number of cases than the novel catheter group during the study period, with 230 cases observed, which exceeded the initially calculated sample size of 105 cases. Therefore, the number of cases observed during the observation period was used to define the sample size.

Statistical analysis was performed using SPSS version 17.0 (IBM Corp., Armonk, NY, United States) and R statistical package version 3.2.4 (R Foundation for Statistical Computing, Vienna, Austria). Continuous variables are expressed as medians and interquartile ranges, whereas categorical variables are presented as percentages and absolute numbers. Continuous variables were compared using the Mann-Whitney U-test, whereas categorical variables were compared using Fisher exact tests. All P values were two-sided, and statistical significance was set at P < 0.05. All authors have access to and reviewed the study data and approved the final manuscript.

RESULTS
Baseline characteristics

A total of 342 patients were identified using database analysis. Among these, 230 patients underwent ERCP with existing catheters, and 112 with novel catheters. Table 1 describes the patients’ baseline characteristics. No significant differences were noted in age, sex, or primary disease between the existing and novel catheter groups. Similarly, no significant differences were observed in anatomical factors affecting bile duct cannulation[13-15], such as parapapillary diverticulum and long oral ridge, between the two groups. Further, no significant difference was noted between expert and non-expert physicians who performed the procedure in the two groups.

Table 1 Baseline characteristics of the existing and novel catheter groups, n (%).
Character
Existing catheter group (n = 230)
Novel catheter group (n = 112)
P value
Age median (range) 77 (29-97)80.5 (44-104)0.84
Sex (male/female)144/9656/560.874
Primary disease
Benign disease147 (63.9)73 (65.1)-
Bile duct stones134 (58.2)66 (58.9)-
Benign bile duct stricture6 (2.6)2 (1.8)-
Other (benign)7 (3.0)5 (4.5)-
Malignant disease83 (36.1)39 (34.8)-
Pancreatic cancer33 (14.3)16 (14.2)-
Cholangiocarcinoma46 (20.0)22 (19.6)-
Other (malignant)4 (1.7)1 (0.9)-
Benign/malignant disease147/8373/390.90
Parapapillary diverticular papilla60 (26.1)27 (24.1)0.79
Oral protrusion-large60 (26.1)28 (25.0)0.90
Expert/non-expert115/11564/480.25
Overall results

Table 2 presents the overall treatment results. The overall rates of bile duct cannulation were 98.2% and 99.1% in the existing and novel catheter groups, respectively, with no significant differences. Bile duct cannulation was not possible in five patients (1.5%): One patient underwent repeat ERCP to allow bile duct cannulation, three underwent EUS-guided hepaticogastrostomy, and one underwent bile duct cannulation using the EUS-guided rendezvous technique. The frequencies of difficult cannulation were 41.6% with existing catheters and 32.4% with the novel catheter, with no significant difference. In contrast, the rates of bile duct cannulation with the standard technique were 74.3% for existing catheters and 82.9% for the novel catheter, with a significant difference (P = 0.042). The incidences of AE were 5.2% in the existing catheter group and 4.5% in the novel catheter group, with no significant difference. The incidences of PEP were 4.3% in the existing catheter group and 2.7% in the novel catheter group, with no significant difference observed.

Table 2 Overall outcomes for each group, n (%).
Character
Existing catheter group (n = 230)
Novel catheter group (n = 112)
P value
Cannulation success rate98.3% (226/230)99.1% (111/112)0.47
Number of attempts of cannulation, median (range)3 (1-20)3 (1-10)0.58
Difficult cannulation (> 5 times)94 (40.9)36 (32.1)0.074
Cannulation success rate with the standard technique73.0% (168/230)82.1% (92/112)0.042
Rescue technique
Switch to sphincterotomes8 (3.5)00.039
Pancreatic duct GW method14 (6.1)2 (1.8)0.059
Precut35 (15.2)17 (15.3)0.56
Two devices in one channel method1 (0.4)00.67
Cannulation failure4 (1.7)1 (0.9)0.47
Re-ERCP1 (0.4)00.67
EUS-HGS2 (0.9)1 (0.9)0.70
EUS-rendezvous1 (0.4)00.67
Adverse event
Total12 (5.2)5 (4.5)0.70
Bleeding2 (0.9)2 (1.8)0.60
PEP10 (4.3)3 (2.7)0.59
Mild9 (3.9)2 (1.8)0.51
Moderate disease1 (0.4)1 (0.9)0.55
Severe disease00-
Non-expert treatment performance

Table 3 presents the treatment performance results achieved by non-experts. The overall rates of bile duct cannulation were 99.1% in the existing catheter group and 100% in the novel catheter group, with no significant difference. The frequencies of difficult cannulation were 49.1% and 52.1% in the existing and novel catheter groups, respectively, with no significant differences. The rates of bile duct cannulation using the standard technique were 79.1% for the existing catheter group and 83.3% for the novel catheter group, with no significant differences. The incidences of AE were 3.5% in the existing catheter group and 6.3% in the novel catheter group, with no significant difference, and those of PEP were 2.6% in the existing catheter group and 2.1% in the novel, with no significant difference.

Table 3 Outcomes for each group when a non-expert is the practitioner, n (%).
Character
Existing catheter group (n = 115)
Novel catheter group (n = 48)
P value
Cannulation success rate99.1% (114/115)100% (48/48)0.71
Number of attempts of cannulation median (range)4.5 (1-20)5 (1-10)0.67
Difficult cannulation (> 5 times)56 (48.7)25 (52.1)0.73
Cannulation success rate with the standard technique79.1% (91/115)83.3% (40/48)0.66
Rescue technique
Switch to sphincterotomes2 (1.7)00.47
Pancreatic duct GW method5 (4.3)1 (2.1)0.67
Precut13 (11.3)7 (14.6)0.60
Two devices in one channel method1 (0.9)00.69
Cannulation failure1 (0.9)00.69
Re-ERCP00-
EUS-HGS1 (0.9)00.69
EUS-rendezvous00-
Adverse event
Total4 (3.5)3 (6.3)0.50
Bleeding1 (0.9)2 (4.2)0.21
PEP3 (2.6)1 (2.1)0.66
Mild disease3 (2.6)1 (2.1)0.66
Moderate disease00-
Severe disease00-
Expert treatment performance

Table 4 presents the treatment outcomes achieved by experts. The overall rates of bile duct cannulation were 97.3% and 98.4% in the existing and novel catheter groups, respectively, with no significant differences. The frequencies of difficult cannulation were 33.0% and 17.4% in the existing and novel catheter groups, respectively, with significantly less difficult cannulation in the novel catheter group (P = 0.019). The rates of bile duct cannulation with the standard technique were 65.2% for the existing catheters and 81.3% for the novel catheter, with a significant difference (P = 0.017). The incidences of AE were 7.0% in the existing catheter group and 3.1% in the novel catheter group, with no significant difference. The incidences of PEP were 6.1% in the existing catheter group and 3.1% in the novel catheter group, with no significant difference.

Table 4 Outcome of each group when an expert is the practitioner, n (%).
Character
Existing catheter group (n = 115)
Novel catheter group (n = 64)
P value
Cannulation success rate97.3% (112/115)98.4% (63/64)0.55
Number of attempts of cannulation median (range)2 (1-18)2 (1-10)0.67
Difficult cannulation (> 5 times)37 (32.1)11 (17.2)0.021
Cannulation success rate with the standard technique65.2% (75/115)81.3% (52/64)0.017
Rescue technique
Switch to sphincterotomes6 (5.2)00.067
Pancreatic duct GW method9 (7.8)1.6% (1/64)0.073
Precut22 (19.1)15.6% (10/64)0.36
Two devices in one channel method00-
Cannulation failure3 (2.7)1 (1.6)0.55
Re-ERCP1 (0.9)00.64
EUS-HGS1(0.9)1 (1.6)0.59
EUS-rendezvous1 (0.9)00.64
Adverse event
Total8 (7.0)2 (3.1)0.24
Bleeding1 (0.9)00.64
PEP7 (6.1)2 (3.1)0.31
Mild disease6 (5.2)1 (1.6)0.39
Moderate disease1 (0.9)1 (1.6)0.64
Severe disease00-
DISCUSSION

In this study, we explored the usefulness of bile duct cannulation using a novel catheter in ERCP. Selective bile duct cannulation is an important step in ERCP, as it serves as a gateway to subsequent interventions. Moreover, patients with difficult bile duct cannulation are at high risk for PEP[8], underscoring the importance of facilitating this aspect of the procedure.

Our investigation revealed that the use of the novel catheter improved the rate of bile duct cannulation using the standard technique. This improvement could potentially be attributed to the catheter’s chamfered tip and softness, facilitating its alignment with the bile duct axis. This finding was supported by the fact that no cases of sphincterotome conversion were noted in the novel catheter group. The sphincterotome catheter can be adjusted by stretching the knife in the direction of the catheter, making it easier to look up and align with the bile duct axis, with a study reporting that the rate of bile duct cannulation was higher with the sphincterotome than with a conventional contrast catheter[20]. However, the characteristics of the new catheter suggest that it can be aligned with the bile duct axis without using a sphincterotome.

The rate of bile duct cannulation was higher with the novel catheter using the standard technique than with existing catheters; however, the overall rate showed a trend toward a lower incidence of difficult cannulations, but the difference was not statistically significant. Difficult cannulation is considered a risk factor for PEP[19]; therefore, reducing the frequency is important to reduce the risk of PEP and perform safe ERCP. To examine the results of this study in detail, we determined whether the participating physicians were experts or non-experts. No significant differences were observed between the novel and the existing catheter groups. Meanwhile, the use of novel catheters in the expert group decreased the frequency of difficult cannulation and increased the bile duct cannulation rate using the standard technique compared with the use of existing catheters. However, the incidence of AE was similar between the two groups. These results suggest that using the novel catheter facilitated bile duct cannulation in the expert group. This may be because the experts could understand the characteristics of the novel catheter and orient it toward the bile duct axis. Consequently, treatment outcomes may be more favorable.

Furthermore, rescue techniques such as the double- GW technique with a GW placed in the pancreatic duct and pre-cut have been reported to increase the risk of PEP[19,24,25]. Therefore, our study’s results hold significance, as a higher rate of bile duct cannulation using only the standard technique may reduce the risk of PEP. The incidences of AE were 5.2% in the existing catheter group and 4.5% in the novel; however, this difference was not significant. The incidences of pancreatitis after ERCP decreased to 4.3% and 2.7% in the existing and novel catheter groups, respectively. However, there was a trend toward fewer cases reported in both groups, although the difference was not significant[17]. No serious complications were observed in either of the groups. Reportedly, the incidence of AE increased when ERCP was performed by non-experts or at institutions with limited experience. However, in this study, even when non-experts performed ERCP, the incidences of incidental injury were 3.5% in the existing catheter group and 6.3% in the novel catheter group, with a low incidence in both groups. The incidences of pancreatitis after ERCP were 2.6% in the existing catheter group and 2.1% in the novel catheter group, even when non-experts performed catheterization. In this study, non-experts were assisted by an expert in the supervisory position when performing ERCP. As a result, the procedure could be performed safely, and the incidence of accidental injury was low in both groups.

In recent years, endoscopic ultrasonography-guided biliary drainage has gained popularity as an alternative in patients who have difficulty with ERCP[26-28]. The treatment results were excellent and comparable with those of ERCP[29]. However, there are cases in which EUS-guided biliary drainage cannot be performed, such as in patients with very narrow bile ducts or large amounts of ascites. Therefore, improving the success rate of ERCP is important. Our study highlights the efficacy of the novel catheter in improving the rate of bile duct cannulation using the conventional method, thus filling a notable gap in existing literature.

This study has some limitations. First, this was a single-center retrospective study, with a small sample size. Second, because there were multiple surgeons, the choice of the ERCP technique was not constant and depended on the choice of the endoscopist, which may have led to bias. In the future, it would be desirable to study a larger number of cases considering all these factors. In addition to a larger sample size, performing a randomized controlled trial to compare the efficacy and safety of new and conventional catheters would be helpful.

CONCLUSION

This novel catheter improved the success rate of bile duct cannulation using the conventional method. Further, its application by experts has shown promise in reducing the frequency of difficult cannulation, underscoring its utility in clinical practice.

Footnotes

Provenance and peer review: Unsolicited article; Externally peer reviewed.

Peer-review model: Single blind

Specialty type: Gastroenterology and hepatology

Country of origin: Japan

Peer-review report’s classification

Scientific Quality: Grade B

Novelty: Grade B

Creativity or Innovation: Grade B

Scientific Significance: Grade B

P-Reviewer: Sun DM S-Editor: Bai Y L-Editor: A P-Editor: Zhang L

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