Published online Jan 7, 2027. doi: 10.3748/wjg.125390
Revised: August 3, 2026
Accepted: September 9, 2026
Published online: January 7, 2027
Processing time: 126 Days and 23.3 Hours
Cholangioscopy is an important tool used for minimally invasive biliary surgery, and image quality plays a crucial role in the diagnosis and treatment of biliary lesions. Currently, both digital cholangioscopy and fiberoptic cholangioscopy are widely used in clinical settings. However, from the perspective of clinical dia
To evaluate the efficacy and safety of disposable digital single-operator cholangioscopy (DSOC) in terms of diagnostic and therapeutic procedures.
A total of 114 participants were enrolled from January 2022 to December 2022. The participants were randomized at a ratio of 1:1 to the test and control groups. Disposable DSOCs were employed in the test group, whereas reusable fiberoptic single-operator cholangioscopies (FSOCs) were used in the control group. The primary outcome was measured by assessing the image quality compliance rate for clinical diagnostic requirements. The secondary outcome was assessed by score-based device performance.
The image quality compliance rates for clinical diagnostic requirements were observed to be 98.28% in the DSOC group, and 98.21% in the FSOC group (rate difference: 0.0615%; 95% confidence interval: -7.4994% to 7.8518%). 92.9% of the images were graded as excellent in the DSOC group, whereas 16.07% in the FSOC group (P < 0.05). DSOC performed better in terms of the smoothness of insertion and withdrawal, as well as the sealability of the instrument channel and flexibility of the bending section. Additionally, the accessory could cooperate closely with the instrument channel to complete the procedure in the DSOC group (P < 0.05). The overall rate of reported adverse events was 46.6% (27/58) in the DSOC group compared with 51.8% (29/56) in the FSOC group (P > 0.05).
DSOC was significantly superior to FSOC in terms of image quality, smoothness, sealability and flexibility. Digital cholangioscopy represents a growing trend in minimally invasive biliary surgery.
Core Tip: This randomized study compared digital cholangioscopy with fiberoptic cholangioscopy, from the perspective of clinical diagnostic requirements. The results revealed that digital cholangioscopy was significantly superior to fiberoptic cholangioscopy in terms of image quality, smoothness, sealability and flexibility, although the image quality compliance rates for clinical diagnostic requirements were comparable between the procedures. Additionally, the accessory could cooperate better with the instrument channel to complete the digital cholangioscopy procedure. Digital cholangioscopy represents a growing trend in minimally invasive biliary surgery.
- Citation: Xie Y, Qiu JY, Ju M, Cai SR, Kang GF, Guo P, Tang ZL, Cao PH, Zhong KB. Efficacy and safety of disposable digital single-operator cholangioscopy: A noninferiority, multicenter, randomized, open-label, blinded endpoint trial. World J Gastroenterol 2027; 33(1): 125390
- URL: https://www.wjgnet.com/1007-9327/full/v33/i1/125390.htm
- DOI: https://dx.doi.org/10.3748/wjg.125390
Biliary diseases (including biliary strictures and bile duct stones) are commonly encountered and can occasionally present challenges for expert physicians. Cholangioscopy is an important tool used for minimally invasive biliary surgery, and image quality plays a crucial role in the diagnosis and treatment of biliary lesions. Fiberoptic cholangioscopy was first introduced in the 1970s[1] but had limited applications because of low-quality images and time-consuming manipulation[2]. Two expert endoscopists were needed at that time to perform the procedure. In 2007, the first fiberoptic single-operator cholangioscopy (FSOC, SpyGlassTM Direct Visualization System, Boston Scientific Corp, Natick, MA, United States) was introduced to clinical practice. The emergence of FSOC enabled a single endoscopist to complete cholangioscopic procedures and resulted in the creation of several apparatuses, such as biopsy forceps, laser lithotripters and electrohydraulic lithotripters; these innovations allowed physicians to obtain access to hepatic biliary trees under direct visualization, thus yielding favorable results in both diagnostic and therapeutic areas[3-7]. In 2015, the first digital single-operator cholangioscopy (DSOC, SpyGlassTM Digital-Imaging System, Boston Scientific Corp, Natick, MA, United States) was released for public use and involved the utilization of a digital probe instead of a fiberoptic probe, thus further increasing image resolution and promoting operation efficiency[8-11]. However, from the perspective of clinical diagnostic requirements, few head-to-head studies have compared DSOC and FSOC, despite the fact that DSOC can improve cholangioscopic procedures. Thus, we performed a randomized multicenter study to evaluate the efficacy and safety of DSOC compared with FSOC in terms of diagnostic and therapeutic procedures.
This trial was a noninferiority, multicenter, randomized, open-label and blinded endpoint clinical study (Figure 1). It was conducted in 3 teaching hospitals in China. The participants were enrolled from January 2022 to December 2022 and followed up from February 2022 to January 2023. The trial protocol was approved and monitored by the Medical Ethics Committee of Zhujiang Hospital, Southern Medical University, No. 2022-QX-004-01. Written informed consent was obtained from each participant or legal representative. We followed the CONSORT reporting guidelines.
The following inclusion criteria for study eligibility were utilized: (1) Participants aged 18 to 75 years, regardless of sex; (2) Participants who needed cholangioscopic examinations or therapies; and (3) Participants who voluntarily participated in the trial. The following detailed exclusion criteria were utilized: (1) Participants with liver cirrhosis ascites; (2) Participants with bleeding tendencies; (3) Participants with unstable or complicated diseases, including acute biliary infections, organ failure, malignant tumors or hypoproteinemia (albumin < 30 g/L); (4) Pregnant or lactating women; (5) Participants with mental illness; and (6) Participants who had participated in other trials 30 days before enrollment in the study.
Participants were randomized at a 1:1 ratio to the test and control groups according to the inclusion and exclusion criteria specified in the trial protocol. Single-use DSOC (RP-H-C21, Redpine, China) was used in the test group for photography, observation, diagnosis and treatment, whereas reusable FSOC (CHF-P60, Olympus, Japan) was used in the control group (Figure 2).
Randomization was performed by a professional statistician using SAS software. Randomized assignment tables were generated by using the PLAN process of SAS software, which was simulated via a computer. This clinical trial adopted an open design because the cholangioscopies used in the DSOC and FSOC groups differed in appearance.
Participants were randomized to the DSOC and FSOC groups. During the cholangioscopic operations, images were obtained for each participant (including the luminal mucosa and lesions of the biliary tracts) when the operator considered the images to have achieved the optimal resolution. These images were classified as excellent, good, ordinary, poor, or very poor according to the evaluation criteria, with a rigid hierarchy being utilized (Supplementary Table 1). The image quality was evaluated by an independent team that included three hepato-biliary surgery doctors who did not perform cholangioscopic operations on the participants. Given that the evaluation criteria were inevitably subject to a certain degree of subjective influence from the evaluators, the final determination of image quality was based on the assessments upon which two evaluators concurred. If the assessments of the three evaluators were mutually discordant, then a fourth evaluator was introduced, and the definitive judgment was rendered in accordance with the assessments that were consistent between any two evaluators. If each image of one participant was rated as being excellent or good, the image qualities of the participant were considered to have met the clinical diagnostic requirements. If any one of the images was rated as being ordinary, poor or very poor, the image qualities of the participant were considered to have not met the clinical diagnostic requirements. Moreover, both DSOC and FSOC were scored by the operators according to their specific performances (Supplementary Table 2).
The primary outcome was measured by assessing the image quality compliance rate for clinical diagnostic requirements. The following formula was used to calculate the rate: Image quality compliance rate for clinical diagnostic requirements = (the number of participants whose image quality met clinical diagnostic requirements/the total number of participants who underwent cholangioscopic operations) × 100%. The secondary outcome was assessed by evaluating the device performance, which was scored based on insertion, withdrawal, sealing and angulation for cholangioscopy, in addition to accessory insertion, withdrawal and compatibility.
Adverse events in this trial could have possibly involved bleeding, infection, regurgitation cholangitis, acute pancreatitis and perforation of the biliary tract. When the abovementioned adverse events occurred, active measures were performed to treat the participants and we obtained detailed medical records.
In this trial, the estimated image quality compliance rate for clinical diagnostic requirements was 97%, with a predefined difference between the DSOC and FSOC groups of D = 0. When considering possible deviations in actual clinical practice, the investigators and statisticians set a noninferiority margin of Δ = -10% (DSOC group-FSOC group) for this trial. The following parameters were utilized: Δ = 0.05 (two-sided) and power (1-β) = 0.8. We calculated a sample size of 92 participants (46 participants per group) by using the sample size calculation formula for a noninferiority trial. On the basis of an anticipated dropout rate of approximately 20% during the trial, along with the requirements for central sample allocation and block randomization, the sample size per group was increased to 58 participants, thus resulting in a total sample size of 116 participants.
Continuous variables were presented as the mean ± SD, and the data were analyzed via the independent two-sample t-test. Categorical data were presented as frequencies, and the data were analyzed using the χ2 or Fisher’s exact test. All P values were 2-sided and considered to be statistically significant when the value was less than 0.05. Statistical analyses were performed by using SAS 9.3 software.
A total of 114 participants were enrolled at 3 university teaching hospitals in China, of whom 58 participants were in the DSOC group, with an average age of 57.09 ± 12.86 years; moreover, 56 participants were in the FSOC group, with an average age of 57.50 ± 13.46 years. The DSOC and FSOC groups were matched at baseline, and no significant differences were observed in sex, age, weight, pulse or blood pressure among the groups. Blood test results did not markedly differ between the groups, including blood and coagulation routine tests, as well as liver and renal function measurements (P > 0.05, Table 1). Overall, the clinical characteristics of the enrolled participants were well balanced, and they were observed to be homogeneous between the groups before the cholangioscopic operations. The participants underwent subsequent cholangioscopic operations via laparoscopic choledochendysis or T-tube sinus tract in both the DSOC and FSOC groups, and significant differences were not observed in terms of how the cholangioscopy could obtain access to the common bile duct; furthermore, no differences were observed with respect to the conditions in which the stone retrieval baskets were used (P > 0.05; Table 2).
| Characteristics | DSOC group | FSOC group | P value |
| Sex | 0.5763 | ||
| Male | 27 (46.55) | 29 (51.79) | |
| Female | 31 (53.45) | 27 (48.21) | |
| Age (years) | 57.09 ± 12.86 | 57.50 ± 13.46 | 0.8683 |
| Weight (kg) | 57.79 ± 10.95 | 59.46 ± 11.50 | 0.4284 |
| Pulse (bpm) | 76.67 ± 12.52 | 76.09 ± 13.14 | 0.8087 |
| SBP (mmHg) | 123.90 ± 19.74 | 125.71 ± 20.91 | 0.6340 |
| DBP (mmHg) | 76.95 ± 11.76 | 77.32 ± 11.07 | 0.8619 |
| RBC (1012/L) | 4.13 ± 0.63 | 4.31 ± 0.63 | 0.1351 |
| WBC (109/L) | 6.80 ± 3.75 | 6.74 ± 2.83 | 0.9150 |
| PLT (109/L) | 213.12 ± 80.13 | 226.86 ± 78.71 | 0.3580 |
| PT (seconds) | 12.42 ± 1.27 | 12.25 ± 1.18 | 0.4639 |
| APTT (seconds) | 31.46 ± 4.05 | 30.66 ± 3.96 | 0.2927 |
| Alb (g/L) | 41.00 ± 4.54 | 41.55 ± 4.98 | 0.5373 |
| ALT (U/L) | 77.58 ± 115.01 | 88.00 ± 112.27 | 0.6256 |
| Cr (μmol/L) | 76.49 ± 28.33 | 71.49 ± 15.36 | 0.2463 |
| BUN (mmol/L) | 4.81 ± 2.09 | 4.39 ± 1.44 | 0.2195 |
| Surgical approaches | DSOC group | FSOC group | P value |
| Laparoscopic choledochendysis | 24 (41.38) | 28 (50.00) | 0.3556 |
| T-tube sinus tract | 34 (58.62) | 28 (50.00) | |
| Stone retrieval basket | |||
| Without | 45 (77.59) | 43 (76.79) | 0.9189 |
| With | 13 (22.41) | 13 (23.21) |
In this trial, a total of 169 images were collected from 58 participants in the DSOC group and 168 images were collected from 56 participants in the FSOC group. The locations of the collected images included the common bile duct, the first- and second-order biliary branches, and the confluence of the second-order biliary branches. The contents of the abovementioned images included biliary stones and the mucosa, as well as stone retrieval baskets and holmium laser fibers (Table 3). After evaluation by an independent team, we observed that the image quality of the DSOC group was superior to that of the FSOC group. Overall, 92.9% of the images were graded as excellent in the DSOC group, whereas 16.07% of the images were excellent in the FSOC group (P < 0.05; Table 4). Almost all of the images in both groups met the clinical diagnostic requirements. The image quality compliance rates for clinical diagnostic requirements were 98.28% in the DSOC group and 98.21% in the FSOC group (rate difference: 0.0615%; 95% confidence interval: -7.4994% to 7.8518%). Noninferiority was established, as the lower confidence limit exceeded the prespecified margin of -10% (Table 5).
| Participant numbers based on image contents | DSOC group | FSOC group | P value |
| Common bile duct | 1.0000 | ||
| Absent | 2 (3.45) | 1 (1.79) | |
| Present | 56 (96.55) | 55 (98.21) | |
| First-order biliary branches | 0.4957 | ||
| Absent | 56 (96.55) | 56 (100.00) | |
| Present | 2 (3.45) | 0 (0.00) | |
| Second-order biliary branches | 0.2436 | ||
| Absent | 55 (94.83) | 56 (100.00) | |
| Present | 3 (5.17) | 0 (0.00) | |
| Confluence of second-order biliary branches | 0.0550 | ||
| Absent | 0 (0.00) | 4 (7.14) | |
| Present | 58 (100.00) | 52 (92.86) | |
| Stone | 0.8488 | ||
| Absent | 29 (50.00) | 29 (51.79) | |
| Present | 29 (50.00) | 27 (48.21) | |
| Stone retrieval basket/holmium laser fiber | 0.1339 | ||
| Absent | 33 (56.90) | 24 (42.86) | |
| Present | 25 (43.10) | 32 (57.14) | |
| Biliary mucosa | |||
| Absent | 0 (0.00) | 0 (0.00) | |
| Present | 58 (100.00) | 56 (100.00) | |
| Image numbers based on biliary locations | |||
| Common bile duct | 100 (59.17) | 110 (65.48) | 0.0411 |
| Second-order biliary branches | 5 (2.96) | 0 (0.00) | |
| First-order biliary branches | 2 (1.18) | 0 (0.00) | |
| Confluence of second-order biliary branches | 62 (36.69) | 58 (34.52) | |
| Image numbers based on captured contents | |||
| Stone | 29 (17.16) | 27 (16.07) | 0.6765 |
| Stone retrieval basket/holmium laser fiber | 27 (15.98) | 33 (19.64) | |
| Biliary mucosa | 113 (66.86) | 108 (64.29) |
| Image quality evaluation | DSOC group | FSOC group | P value |
| Excellent | 157 (92.90) | 27 (16.07) | < 0.0001 |
| Good | 11 (6.51) | 140 (83.33) | |
| Ordinary | 1 (0.59) | 1 (0.60) | |
| Very poor | 0 (0.00) | 0 (0.00) | |
| Poor | 0 (0.00) | 0 (0.00) |
| Study group | n | Image quality compliance rate for clinical diagnostic requirements | Rate difference (95%CI) |
| DSOC group | 58 | 57 (98.28) | 0.0615% (-7.4994% to 7.8518%) |
| FSOC group | 56 | 55 (98.21) |
Furthermore, the device performances of the DSOC and FSOC groups were scored by the operator, with focuses on insertion, withdrawal, sealing and angulation for the cholangioscopy, in addition to accessory insertion, withdrawal and compatibility. We observed that the DSOC performed better in terms of the smoothness of insertion and withdrawal, as well as the sealability of the instrument channel, and flexibility of the bending section. Additionally, the accessory could cooperate closely with the instrument channel to complete the procedure in the DSOC (P < 0.05; Table 6).
| Performance metrics | DSOC group | FSOC group | P value |
| Insertion | < 0.0001 | ||
| 1 | 0 (0.00) | 0 (0.00) | |
| 2 | 0 (0.00) | 0 (0.00) | |
| 3 | 0 (0.00) | 0 (0.00) | |
| 4 | 14 (24.14) | 43 (76.79) | |
| 5 | 44 (75.86) | 13 (23.21) | |
| Withdrawal | < 0.0001 | ||
| 1 | 0 (0.00) | 0 (0.00) | |
| 2 | 0 (0.00) | 0 (0.00) | |
| 3 | 0 (0.00) | 0 (0.00) | |
| 4 | 11 (18.97) | 41 (73.21) | |
| 5 | 47 (81.03) | 15 (26.79) | |
| Sealing | 0.0090 | ||
| 1 | 0 (0.00) | 0 (0.00) | |
| 2 | 3 (5.17) | 0 (0.00) | |
| 3 | 5 (8.62) | 15 (26.79) | |
| 4 | 50 (86.21) | 41 (73.21) | |
| Angulation | < 0.0001 | ||
| 1 | 0 (0.00) | 0 (0.00) | |
| 2 | 0 (0.00) | 0 (0.00) | |
| 3 | 3 (5.17) | 8 (14.29) | |
| 4 | 19 (32.76) | 37 (66.07) | |
| 5 | 36 (62.07) | 11 (19.64) | |
| Accessory insertion and withdrawal | 0.2923 | ||
| 1 | 0 (0.00) | 0 (0.00) | |
| 2 | 0 (0.00) | 0 (0.00) | |
| 3 | 2 (6.25) | 2 (5.71) | |
| 4 | 14 (43.75) | 22 (62.86) | |
| 5 | 16 (50.00) | 11 (31.43) | |
| Accessory compatibility | 0.0016 | ||
| 1 | 0 (0.00) | 0 (0.00) | |
| 2 | 0 (0.00) | 0 (0.00) | |
| 3 | 4 (12.50) | 2 (5.71) | |
| 4 | 9 (28.12) | 25 (71.43) | |
| 5 | 19 (59.38) | 8 (22.86) |
The overall rate of reported adverse events was 46.6% (27/58) in the DSOC group compared with 51.8% (29/56) in the FSOC group; however, marked differences were not observed in the proportions of adverse events between the two groups, and the adverse events were not correlated with the type of cholangioscopies after careful investigation (P > 0.05; Table 7). Major adverse events included fever, abdominal pain, nausea and vomiting. Serious adverse events occurred in both groups. One participant suffered from peritonitis in the DSOC group, and another participant experienced hemorrhagic shock in the FSOC group; however, the two participants recovered after the relevant treatments (Table 8).
| Adverse events | DSOC group | FSOC group | P value |
| Occurrence | 0.576 | ||
| No | 31 (53.4) | 27 (48.2) | |
| Yes | 27 (46.6) | 29 (51.8) | |
| Serious adverse events | |||
| Occurrence | 0.98 | ||
| No | 57 (98.28) | 55 (98.21) | |
| Yes | 1 (1.72) | 1 (1.79) |
| Nonserious events | DSOC group | FSOC group | P value |
| Fever | 5 (8.62) | 6 (10.71) | 0.629 |
| Nausea and vomiting | 4 (6.90) | 2 (3.57) | |
| Abdominal pain | 17 (29.31) | 20 (35.71) | |
| Serious events | |||
| Shock | 0 | 1 (1.79) | 1.000 |
| Peritonitis | 1 (1.72) | 0 |
Currently, both digital and fiberoptic cholangioscopy have been widely used for the diagnosis and treatment of biliary diseases. It appears that digital cholangioscopy can provide higher-resolution images for doctors in contrast with fiberoptic cholangioscopy; however, from the perspective of clinical diagnostic requirements, to our knowledge, head-to-head studies concerning comparisons between the two devices are scarce. Thus, we designed a non-inferiority, mul
A previous cohort study demonstrated that the digital cholangioscopy approach could provide enhanced diagnostic yield, shorter procedure time and less radiation exposure in biliary stone diseases and indeterminate biliary strictures in comparison with fiberoptic cholangioscopy[12]. In another study, digital cholangioscopy was demonstrated to be a feasible and effective option for the management of difficult cholelithiasis, as well as for visually evaluating and obtaining histological samples for indeterminate biliary strictures[13]. However, the referred studies were either retrospective or descriptive in nature, and it was speculated that better digital visualization might explain the abovementioned positive results. To date, no studies have verified the noninferiority of digital cholangioscopy in comparison to fiberoptic approach in terms of image quality. This is a pending issue and a concrete answer is needed. By introducing an inde
Clinical studies are scarce concerning the discrepancy between digital and fiberoptic cholangioscopy methods in operational performance, although results obtained in a bench model revealed that digital cholangioscopy was sig
Originally introduced to clinical practice in the 1970s, fiberoptic cholangioscopy has evolved into digital cholangioscopy with several decades of modifications and refinements. Notably, the digital cholangioscopy approach used in our study involved a single-use endoscopic catheter and a small main unit. The endoscopic catheter was disposable, and the main unit was portable, which could reduce cross-infections and maintenance costs in hospitals (to a certain extent). The advent of endoscopy marked the transition of biliary surgery from the era of open surgery to minimally invasive surgery, thereby broadening the approach to obtain access to hepatic biliary trees, such as percutaneous transhepatic cholangioscopy. The miniaturization of endoscopy may further decrease the luminal size required for interventional tools, thus facilitating the resolution of difficult lesions such as cystic duct calculi[17].
Our study has several limitations. First, the operators were not blinded to the cholangioscopies because the features of the digital cholangioscopies clearly distinguished them from those of the fiberoptic versions. Second, participants with biliary tumors were not included in our study; thus, images for biliary tumors were absent, and comparisons between digital and fiberoptic cholangioscopy approaches were lacking in terms of image quality for biliary tumors, which inevitably limited the general applicability of the conclusions. Therefore, it should be stated that the current conclusions primarily apply to benign biliary tract diseases and that the findings should not be overgeneralized to malignant diseases. Finally, the device performance was assessed by a single operator in both the test and control groups at a single center, which may have been biased in terms of manipulation, although the operators were experienced users of both digital and fiberoptic cholangioscopy methods.
Disposable digital cholangioscopy was significantly superior to fiberoptic cholangioscopy in terms of image quality, smoothness, sealability and flexibility. Digital cholangioscopy represents a growing trend in minimally invasive biliary surgery.
We thanked Tang JM (Jian-Ming Tang) and Li N (Nan Li) for offering disposable digital single-operator cholangioscopes in this trial.
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