Dataset Information

Radioactive stent insertion for inoperable hilar cholangiocarcinoma: a prospective randomized controlled trial.

ABSTRACT:

Introduction

Hilar cholangiocarcinoma (HC) is the leading cause of hilar biliary obstruction. Radioactive stent insertion has been utilized extensively for inoperable HC patients.

Aim

To assess the relative clinical outcomes of inoperable HC patients who underwent either normal or radioactive stent insertion.

Material and methods

This single-center, prospective, randomized, open-label study enrolled 90 inoperable HC patients from April 2021 to March 2022 and randomly assigned them to normal or radioactive stent groups (n = 45/group), with clinical data then being compared between these groups.

Results

Technical success rates in the normal and radioactive stent insertion groups were 93.3% and 97.9%, respectively (p = 1.000), and clinical success rates were similarly consistent in both groups (95.3% vs. 97.7%, p = 0.983). Individuals in the radioactive stent group exhibited significantly longer median stent patency as compared to the normal stent group (195 days vs. 115 days, p < 0.001), and median overall survival (OS) was also significantly increased in the normal stent group (242 days vs. 125 days, p = 0.002). In the normal stent insertion group, 6 (14.3%) and 5 (11.9%) patients experienced early and late postoperative complications, respectively. Additionally, early and late postoperative complications impacted 7 (16.3%) and 8 (18.6%) patients in the radioactive stent insertion group, respectively. Complication rates were comparable in these 2 patient groups.

Conclusions

Radioactive stent insertion represents a safe and effective strategy for patients with inoperable HC, potentially contributing to prolonged stent patency and OS relative to normal stent insertion.

SUBMITTER: Song T

PROVIDER: S-EPMC10481449 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Radioactive stent insertion for inoperable hilar cholangiocarcinoma: a prospective randomized controlled trial.

Song Tao T Feng An-Qiang AQ Fu Yu-Fei YF Cao Chi C Wang You-Bin YB Feng Jin-Ling JL

Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques 20221222 2

<h4>Introduction</h4>Hilar cholangiocarcinoma (HC) is the leading cause of hilar biliary obstruction. Radioactive stent insertion has been utilized extensively for inoperable HC patients.<h4>Aim</h4>To assess the relative clinical outcomes of inoperable HC patients who underwent either normal or radioactive stent insertion.<h4>Material and methods</h4>This single-center, prospective, randomized, open-label study enrolled 90 inoperable HC patients from April 2021 to March 2022 and randomly assign ...[more]

PMID: 37680729

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Project description:BackgroundUreteral stents, such as double-J stents, have become indispensable in urologic procedures but are associated with complications like hematuria and pain. While the advancement of artificial intelligence (AI) technology has led to its increasing application in the health sector, AI has not been used to provide information on potential complications and to facilitate subsequent measures in the event of such complications.ObjectiveThis study aimed to assess the effectiveness of an AI-based prediction tool in providing patients with information about potential complications from ureteroscopy and ureteric stent placement and indicating the need for early additional therapy.MethodsOverall, 28 patients (aged 20-70 years) who underwent ureteral stent insertion for the first time without a history of psychological illness were consecutively included. A "reassurance-call" service was set up to equip patients with details about the procedure and postprocedure care, to monitor for complications and their severity. Patients were randomly allocated into 2 groups, reassurance-call by AI (group 1) and reassurance-call by humans (group 2). The primary outcome was the level of satisfaction with the reassurance-call service itself, measured using a Likert scale. Secondary outcomes included satisfaction with the AI-assisted reassurance-call service, also measured using a Likert scale, and the level of satisfaction (Likert scale and Visual Analogue Scale [VAS]) and anxiety (State-Trait Anxiety Inventory and VAS) related to managing complications for both groups.ResultsOf the 28 recruited patients (14 in each group), 1 patient in group 2 dropped out. Baseline characteristics of patients showed no significant differences (all P>.05). Satisfaction with reassurance-call averaged 4.14 (SD 0.66; group 1) and 4.54 (SD 0.52; group 2), with no significant difference between AI and humans (P=.11). AI-assisted reassurance-call satisfaction averaged 3.43 (SD 0.94). Satisfaction about the management of complications using the Likert scale averaged 3.79 (SD 0.70) and 4.23 (SD 0.83), respectively, showing no significant difference (P=.14), but a significant difference was observed when using the VAS (P=.01), with 6.64 (SD 2.13) in group 1 and 8.69 (SD 1.80) in group 2. Anxiety about complications using the State-Trait Anxiety Inventory averaged 36.43 (SD 9.17) and 39.23 (SD 8.51; P=.33), while anxiety assessed with VAS averaged 4.86 (SD 2.28) and 3.46 (SD 3.38; P=.18), respectively, showing no significant differences. Multiple regression analysis was performed on all outcomes, and humans showed superior satisfaction than AI in the management of complications. Otherwise, most of the other variables showed no significant differences (P.>05).ConclusionsThis is the first study to use AI for patient reassurance regarding complications after ureteric stent placement. The study found that patients were similarly satisfied for reassurance calls conducted by AI or humans. Further research in larger populations is warranted to confirm these findings.Trial registrationClinical Research Information System KCT0008062; https://tinyurl.com/4s8725w2.

Dataset Information

Radioactive stent insertion for inoperable hilar cholangiocarcinoma: a prospective randomized controlled trial.

Introduction

Aim

Material and methods

Results

Conclusions

Publications

Radioactive stent insertion for inoperable hilar cholangiocarcinoma: a prospective randomized controlled trial.

Similar Datasets

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