T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial

Trials

Tao Zhu¹  Yi-jun Zhao²  Zi-xiang Chen²  Xiao-ping Geng²  Jiang-ming Chen²  Fu-bao Liu²  Kun Xie²  Xi-yang Yan³ 

[1] Department of Anesthesiology, The First Affiliated Hospital of USTC;Department of Surgery, The First Affiliated Hospital of Anhui Medical University;Department of Surgery, The Second Affiliated Hospital of Anhui Medical University;

关键词: Hepatolithiasis;    Sphincter of Oddi;    Choledochojejunostomy;    T-tube drainage;   

DOI  :  10.1186/s13063-020-04483-z

来源: DOAJ

【 摘 要 】

Abstract Background Residual and recurrent stones remain one of the most important challenges of hepatolithiasis and are reported in 20 to 50% of patients treated for this condition. To date, the two most common surgical procedures performed for hepatolithiasis are choledochojejunostomy and T-tube drainage for biliary drainage. The goal of the present study was to evaluate the therapeutic safety and perioperative and long-term outcomes of choledochojejunostomy versus T-tube drainage for hepatolithiasis patients with sphincter of Oddi laxity (SOL). Methods/design In total, 210 patients who met the following eligibility criteria were included and were randomized to the choledochojejunostomy arm or T-tube drainage arm in a 1:1 ratio: (1) diagnosed with hepatolithiasis with SOL during surgery; (2) underwent foci removal, stone extraction and stricture correction during the operation; (3) provided written informed consent; (4) was willing to complete a 3-year follow-up; and (5) aged between 18 and 70 years. The primary efficacy endpoint of the trial will be the incidence of biliary complications (stone recurrence, biliary stricture, cholangitis) during the 3 years after surgery. The secondary outcomes will be the surgical, perioperative and long-term follow-up outcomes. Discussion This is a prospective, single-centre and randomized controlled two-group parallel trial designed to demonstrate which drainage method (Roux-en-Y hepaticojejunostomy or T-tube drainage) can better reduce biliary complications (stone recurrence, biliary stricture, cholangitis) in hepatolithiasis patients with SOL. Trial registration Clinical Trials.gov: NCT04218669 . Registered on 6 January 2020.

【 授权许可】

Unknown