Efficacy and safety of disposable digital single-operator cholangioscopy: A noninferiority, multicenter, randomized, open-label, blinded endpoint trial

doi:10.3748/wjg.125390

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Controlled Trial

Copyright: ©Author(s) 2027. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Gastroenterol. Jan 7, 2027; 33(1): 125390
Published online Jan 7, 2027. doi: 10.3748/wjg.125390

Table 1 Demographic and clinical characteristics at baseline, n (%)/mean ± SD

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

SBP: Systolic blood pressure; DBP: Diastolic blood pressure; RBC: Red blood cell; WBC: White blood cell; PLT: Platelet; PT: Prothrombin time; APTT: Activated partial thromboplastin time; Alb: Albumin; ALT: Alanine aminotransferase; Cr: Creatinine; BUN: Blood urea nitrogen; DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy.

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Table 2 Surgical approaches and concomitant instruments for the cholangioscopy operation, n (%)

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)	0.3556
Stone retrieval basket
Without	45 (77.59)	43 (76.79)	0.9189
With	13 (22.41)	13 (23.21)	0.9189

DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy.

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Table 3 Image acquisition data for cholangioscopy, n (%)

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)

DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy.

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Table 4 Image quality evaluation for cholangioscopy, n (%)

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)

DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy.

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Table 5 Non-inferiority test concerning the image quality compliance rate for clinical diagnostic requirements, n (%)

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)	0.0615% (-7.4994% to 7.8518%)

Rate difference = digital single-operator cholangioscopy group - fiberoptic single-operator cholangioscopy group.

DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy; CI: Confidence interval.

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Table 6 Cholangioscopy performance scored by operator, n (%)

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)

DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy.

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Table 7 Adverse event occurrence status of the participants, n (%)

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)

DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy.

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Table 8 Adverse event profiles of the participants, n (%)

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	1.000

DSOC: Digital single-operator cholangioscopy; FSOC: Fiberoptic single-operator cholangioscopy.

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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

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 [DOI: 10.3748/wjg.125390]

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