T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial
Jiang-Ming Chen, Xi-Yang Yan, Tao Zhu, Zi-Xiang Chen, Yi-Jun Zhao, Kun Xie, Fu-Bao Liu, Xiao-Ping Geng, Jiang-Ming Chen, Xi-Yang Yan, Tao Zhu, Zi-Xiang Chen, Yi-Jun Zhao, Kun Xie, Fu-Bao Liu, Xiao-Ping Geng
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.
Keywords: Choledochojejunostomy; Hepatolithiasis; Sphincter of Oddi; T-tube drainage.
Conflict of interest statement
The authors declare that they have no competing interests.
Figures
References
- Sakpal SV, Babel N, Chamberlain RS. Surgical management of hepatolithiasis. HPB (Oxford) 2009;11(3):194–202. doi: 10.1111/j.1477-2574.2009.00046.x.
- Park JS, Jeong S, Lee DH, Bang BW, Lee JI, Lee JW, et al. Risk factors for long-term outcomes after initial treatment in hepatolithiasis. J Korean Med Sci. 2013;28(11):1627–1631. doi: 10.3346/jkms.2013.28.11.1627.
- Li EL, Yuan RF, Liao WJ, Feng Q, Lei J, Yin XB, et al. Intrahepatic bile duct exploration lithotomy is a useful adjunctive hepatectomy method for bilateral primary hepatolithiasis: an eight-year experience at a single centre. BMC Surg. 2019;19(1):16. doi: 10.1186/s12893-019-0480-1.
- Suzuki Y, Mori T, Yokoyama M, Nakazato T, Abe N, Nakanuma Y, et al. Hepatolithiasis: analysis of Japanese nationwide surveys over a period of 40 years. J Hepatobiliary Pancreat Sci. 2014;21(9):617–622. doi: 10.1002/jhbp.116.
- Chen S, Huang L, Qiu FN, Zhou SQ, Yan ML, Bai YN, et al. Total laparoscopic partial hepatectomy versus open partial hepatectomy for primary left-sided hepatolithiasis: a propensity, long-term follow-up analysis at a single center. Surgery. 2018;163(4):714–720. doi: 10.1016/j.surg.2017.10.053.
- Liu FB, Yu XJ, Wang GB, Zhao YJ, Xie K, Huang F, et al. Preliminary study of a new pathological evolution-based clinical hepatolithiasis classification. World J Gastroenterol. 2015;21(7):2169–2177. doi: 10.3748/wjg.v21.i7.2169.
- Liu L, Liu FB, Zhao YJ, Xie K, Fang Q, Chen ZX, Guo Q. Clinical analysis of choledchojejunostomy combined with T tube external drainage in the treatment of hepatolithiasis. Chin J Pract Surg. 2019;39(6):606–609.
- Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205–213. doi: 10.1097/.
- Terblanche J, Worthley CS, Spence RA. High or low hepaticojejunostomy for bile duct strictures? Surgery. 1990;108(5):828–834.
- Afghani E, Lo SK, Covington PS, Cash BD, Pandol SJ. Sphincter of Oddi function and risk factors for dysfunction. Front Nutr. 2017. 10.3389/fnut.2017.00001.
- Chinese Research Hospital Association. Society for Hepato-pancreato-biliary Surgery. Expert Committee of Public Welfare Scientific Research Program of National Health Commission Expert consensus on application of choledochojejunostomy in hepatolithiasis (2019 edition) Chin J Dig Surg. 2019;18(5):414–418.
- Chen ZH, Liu FB, Wang GB, Zhao YJ, Zhao HC, Xie K, et al. Option of drainage for surgical management of hepatolithias. Chin J Bases Clin Gen Surg. 2014;21(14):1401–1407.
- Okabayashi T, Shima Y, Sumiyoshi T, Sui K, Iwata J, Morita S, et al. Incidence and risk factors of cholangitis after hepaticojejunostomy. J Gastrointest Surg. 2018;22(4):676–683. doi: 10.1007/s11605-017-3532-9.
Source: PubMed