Intraoperative ultrasound enhancing safety of key steps in complex laparoscopic cholecystectomy: a single-blinded randomized controlled trial

Sep 23, 2026

Intraoperative ultrasound (IOUS) is evaluated for improving safety during complex laparoscopic cholecystectomy (LC) in patients with benign gallbladder diseases (BGBD). A single-center randomized controlled trial assigns participants to IOUS-guided or non-IOUS procedures. The primary outcomes assess IOUS ability to identify adherent gastrointestinal tracts, diagnose cystic duct stones, and guide dissection approach of the gallbladder wall using modified GB-RADS criteria. IOUS helps distinguish cystic duct stones and adhered tissues, reduces intraoperative iatrogenic rupture, and supports safer surgical planning in selected high-risk cases.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages16

Reading Time40 min

AccessFree to download

Introduction

Background and rationale for IOUS in complex LC

Challenges and complications in LC safety

Materials and Methods

Study design and randomization

Primary aims and GB-RADS-based guidance

Results

Enrolled population and key findings

Effects on iatrogenic rupture and imaging features

Associations with GB-RADS categories

Intraoperative ultrasound enhancing safety of key steps in complex laparoscopic cholecystectomy: a single-blinded randomized controlled trial Di Zhou, MDa , Shengyu Huang, MDa , Xiaowan Bo, MDb , Mengqian Zhou, RN, BSNc , Guo Ji, MDd , Hao Xi, MDd , Lehang Guo, MDb ,*, Jun Li, MDa ,* Background: Patients with benign gallbladder diseases (BGBD) in China are characterized by prolonged illness duration, recurrent acute inflammation, and poor medical compliance, all increase the difficulty of laparoscopic cholecystectomy (LC) . Complications, including biliary injury, residual stones, and intraoperative iatrogenic rupture (IIR) of the gallbladder wall (GBW) resulting in incidental gallbladder cancer (IGBC) exposure, all warrant vigilance. This study aims to evaluate whether intraoperative ultrasound (IOUS) could enhance the safety of crucial steps of LC. Materials and Methods: Patients enrolled in this single-center randomized controlled trial were initially diagnosed with BGBD and randomly assigned to two groups at a 1:1 ratio, based on whether IOUS scanning was conducted during LC. The primary aim was to assess whether IOUS could: (1) identify adherent gastrointestinal tracts within the surgical field, (2) diagnose cystic duct (CD) stones, and (3) guide the selection of appropriate dissection approaches of GBW to prevent IIR according to the modified Gallbladder Reporting and Data System (GB-RADS) . Results: A total of 152 patients were enrolled in this trial. IOUS helped in differentiating CD stones and adhered gastrointestinal tissues within the surgical area. IOUS effectively reduced IIR (3 .95 vs. 17. 11%, P = 0.017) because it clearly demonstrated the morphology of GBW layers under different levels of inflammation. Additionally, among patients classified as GB-RADS 2B and 2C, the proportion of cases with atypical hyperplasia was notably higher than those with GB-RADS 2A and 1 (P = 0.002) . Conclusions: IOUS plays a pivotal role in enhancing the safety of critical steps during LC surgeries for selected complex cases. Integrating IOUS with GB-RADS is of great value in guiding the selection of safe GBW approaches and preventing IIR in cases with canceration risk. Keywords: benign gallbladder diseases, cystic duct stones, gallbladder wall, intraoperative ultrasound, surgical approach aDepartment of Hepatobiliary Pancreatic Surgery, Shanghai Tenth People’s Hospital, Tongji University, School of Medicine, Shanghai, China, bDepartment of Medical Ultrasound, Shanghai Tenth People’s Hospital, Tongji University, School of Medicine, Shanghai, China, cDepartment of Surgery Center, Shanghai Tenth People’s Hospital, Tongji University, School of Medicine, Shanghai, China and dDepartment of Pathology, Shanghai Tenth People’s Hospital, Tongji University, School of Medicine, Shanghai, China Di Zhou, Shengyu Huang, and Xiaowan Bo contributed equally to this work. Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article. *Corresponding authors. Address: Department of Hepatobiliary Pancreatic Surgery, Shanghai Tenth People’s Hospital, Tongji University, School of Medicine, 301 Middle Yanchang Road, JingAn District, Shanghai, China 200072. Tel.: +86-21-66307363. E-mail: [lijunlancet@tongji.edu.cn](lijunlancet@tongji.edu.cn) (J. Li); Department of Medical Ultrasound, Shanghai Tenth People’s Hospital, Tongji University, School of Medicine, 301 Middle Yanchang Road, JingAn District, Shanghai, China 200072. Tel.: +86-21-66308346. [E-mail: gopp1314@hotmail.com](E-mail: gopp1314@hotmail.com) (L. Guo). Copyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permiss

FAQs

What clinical safety problem does the study target in complex laparoscopic cholecystectomy?

The study targets complications such as biliary injury, residual stones, and intraoperative iatrogenic rupture of the gallbladder wall that can lead to incidental gallbladder cancer exposure.

How does the trial use intraoperative ultrasound during surgery?

During LC, IOUS scanning is performed to help identify adherent gastrointestinal tracts in the surgical field, diagnose cystic duct stones, and guide the gallbladder wall dissection approach according to modified GB-RADS criteria.

What were the main outcomes associated with using IOUS?

IOUS improved differentiation of cystic duct stones and adhered gastrointestinal tissues, and it reduced intraoperative iatrogenic rupture rates (3.95% vs 17.11%, P = 0.017).

Sep 23, 2026

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