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

Di Zhou; Shengyu Huang; Xiaowan Bo; Mengqian Zhou; Guo Ji; Hao Xi; Lehang Guo; Jun Li

doi:10.1097/JS9.0000000000004572

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

Int J Surg. 2025 Dec 19;112(4):9806-9821. doi: 10.1097/JS9.0000000000004572. Online ahead of print.

Authors

Di Zhou¹, Shengyu Huang¹, Xiaowan Bo², Mengqian Zhou³, Guo Ji⁴, Hao Xi⁴, Lehang Guo², Jun Li¹

Affiliations

¹ Department of Hepatobiliary Pancreatic Surgery, Shanghai Tenth People's Hospital, Tongji University, School of Medicine, Shanghai, China.
² Department of Medical Ultrasound, Shanghai Tenth People's Hospital, Tongji University, School of Medicine, Shanghai, China.
³ Department of Surgery Center, Shanghai Tenth People's Hospital, Tongji University, School of Medicine, Shanghai, China.
⁴ Department of Pathology, Shanghai Tenth People's Hospital, Tongji University, School of Medicine, Shanghai, China.

Abstract

Background: Patients with benign gallbladder diseases (BGBD) in China are characterized by prolonged illness duration, recurrent acute inflammation and poor medical compliance, all increase 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 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 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.