Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Apr 23;15(4):e089540.
doi: 10.1136/bmjopen-2024-089540.

Safety and effectiveness of modified laparoscopic transcystic biliary drainage in the treatment of choledocholithiasis: study protocol for a prospective single-arm clinical trial

Yun Yi Zhang #  1 , Gang Wang #  1 , Chunsheng Hou  1 , Zhi Xu  1 , Lixin Wang  1 , Long Cui  1 , Xiaofeng Ling  2 , Lingfu Zhang  2
Affiliations

Safety and effectiveness of modified laparoscopic transcystic biliary drainage in the treatment of choledocholithiasis: study protocol for a prospective single-arm clinical trial

Yun Yi Zhang et al. BMJ Open. .

Abstract

Introduction: Several techniques are used for laparoscopic treatment of gallstone disease with biliary duct stone, but each approach has indications and shortcomings. We have developed a modified laparoscopic transcystic biliary drainage for the management of cholecysto-choledocholithiasis. The hypothesis is that the modified laparoscopic transcystic biliary drainage will reduce morbidity from around 15% to less than 5%. The aim of this study is to assess the safety and efficacy of the modified laparoscopic transcystic biliary drainage.

Methods and analysis: This is a prospective single-arm clinical trial to evaluate the safety and efficacy of the modified laparoscopic transcystic biliary drainage. The recruited 310 patients will be from Peking University Third Hospital. (Here, patients who meet the inclusion criteria will be included in the study, all patients will undergo laparoscopic cholecystectomy with concomitant laparoscopic exploration of the common bile duct and a modified laparoscopic transcystic drainage.) The primary endpoint is the postoperative morbidity and bile leakage. The secondary endpoints of the study are anchoring time of the C-tube, average daily drainage volume, early dislodgement of the C-tube, removal time of the C-tube, pancreatitis, residual stones and postoperative hospital stay. Recurrent stones and biliary stricture will be recorded during 6 months of follow-up. A two-tailed p<0.05 was considered statistically significant. SPSS for Windows V.21.0 (SPSS) software was used.

Ethics and dissemination: This clinical trial was approved by the Medical Science Research Ethics Committee of Peking University Third Hospital (No. M2023223).

Trial registration number: NCT06011941.

Protocol version: V.2, 23 November 2023.

Keywords: Clinical Trial; Hepatobiliary disease; Hepatobiliary surgery; Hepatology.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Preoperative localisation of the puncture point.
Figure 2
Figure 2. Lateral incision of the cystic duct.
Figure 3
Figure 3. C-tube insertion via the cystic duct into the CBD. CBD, common bile duct.
Figure 4
Figure 4. Cystic duct suture.
See this image and copyright information in PMC

References

    1. Collins C, Maguire D, Ireland A, et al. A prospective study of common bile duct calculi in patients undergoing laparoscopic cholecystectomy: natural history of choledocholithiasis revisited. Ann Surg. 2004;239:28–33. doi: 10.1097/01.sla.0000103069.00170.9c. - DOI - PMC - PubMed
    1. Ghazal AH, Sorour MA, El-Riwini M, et al. Single-step treatment of gall bladder and bile duct stones: a combined endoscopic-laparoscopic technique. Int J Surg. 2009;7:338–46. doi: 10.1016/j.ijsu.2009.05.005. - DOI - PubMed
    1. Bradley A, Sami S, Hemadasa N, et al. Decision analysis of minimally invasive management options for cholecysto-choledocholithiasis. Surg Endosc. 2020;34:5211–22. doi: 10.1007/s00464-020-07816-w. - DOI - PubMed
    1. Ricci C, Pagano N, Taffurelli G, et al. Comparison of efficacy and safety of 4 combinations of laparoscopic and intraoperative techniques for management of gallstone disease with biliary duct calculi: a systematic review and Network meta-analysis. JAMA Surg. 2018;153:e181167. doi: 10.1001/jamasurg.2018.1167. - DOI - PMC - PubMed
    1. Basso N, Pizzuto G, Surgo D, et al. Laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy in the treatment of cholecysto-choledocholithiasis. Gastrointest Endosc. 1999;50:532–5. doi: 10.1016/s0016-5107(99)70078-7. - DOI - PubMed

Publication types

Associated data

LinkOut - more resources