In the Tokyo Guidelines 2018 (TG18), endoscopic drainage as the first-line drainage procedure is the recommended treatment for acute cholangitis, regardless of the degree of severity, especially for patients with severe acute cholangitis, except in some cases of mild acute cholangitis in which antibiotics and general supportive care are effective [22]. Previously, two-stage treatment had been recommended for acute cholangitis with bile duct stones, which involves biliary drainage as an initial treatment and endoscopic stone removal after the improvement of cholangitis [23]. Recently, some studies have demonstrated that bile duct stone removal following EST in a single-stage procedure may be considered in patients with mild or moderate acute cholangitis [24, 25]. However, the updated TG18 recommends bile duct stone removal in a two-stage procedure after drainage in patients with a large stone or multiple stones if endoscopic papillary large balloon dilation (EPLBD) is required. Some studies have demonstrated the subset of patients with large (> 1.5 cm), multiple, or impacted stones, which might be difficult to extract with the ERCP approach in a single-stage procedure [26–28]. In addition, our experience with difficult biliary stones (large, multiple, or impacted stones) extracted with the ERCP approach in a single-stage procedure for the management of acute cholangitis is not extensive enough.

With the rapid advancement of minimally invasive surgical techniques, LCBDE has become a widely accepted surgical approach for patients with gallbladder and CBD stones [29]. LCBDE is superior to the ERCP approach in the treatment of choledocholithiasis because it is a single-stage procedure and because it maintains the integrity of the sphincter of Oddi, which is important in young patients [2, 30]. In recent years, accumulating data have demonstrated that LCBDE is safe and feasible for mild or moderate acute cholangitis, but not severe acute cholangitis, due to the high mortality rate [5, 6, 11, 31, 32]. Stone removal at a single session can shorten the hospital stay, and the LCBDE approach is usually performed. Thus, in our center, in the subset of patients with large (> 1.5 cm), multiple, or impacted stones, the LCBDE approach was usually performed by our experienced laparoscopic biliary surgeons. In our current study, 185 patients (72.55%) presented with multiple CBD stones. Ultimately, our choice to perform either ERCP or LCBDE was mostly based on our clinical experience, available equipment, characteristics of the biliary tree, and patient selection, which is consistent with Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines and clinical spotlight review for the clinical application of laparoscopic common bile duct exploration [29, 33].

Traditionally, LCBDE is accompanied by the placement of a T-tube [33], which is a traditional practice accepted by several generations of surgeons. However, this practice is associated with significant T-tube-related complications, including drain site pain, persistent biliary fistula, electrolyte disturbances, biliary peritonitis, and an extended period of having the tube before its removal, which is an inconvenience to the patient [34]. The T-tube-related complication rate is approximately 15% [8]. These complications may prolong the hospital stay, delay postoperative recovery and increase medical expenditure. In our present study, the T-tube-related complication rate was 11.29% (7/62) in the T-tube group, which included electrolyte disturbances (3/62), drain site pain (3/62), biliary retrograde infection (1/62), and biliary peritonitis after T-tube removal or accidental displacement (2/62). Furthermore, T-tube insertion after LCBDE was associated with a prolonged hospital stay, a longer operating time, and higher hospital expenses, which is consistent with previous studies [7, 9, 10, 35, 36].

However, at present, the safety and efficacy of LCBDE with primary closure for patients with CBDS-related acute cholangitis are rarely reported in the literature. To the best of our knowledge, this is the largest series in the literature to date of LCBDE via choledochotomy with primary closure for the treatment of CBDS-related acute cholangitis. In this study, there was no significant difference between the two groups in postoperative mortality, postoperative bile leakage, retained stones, recurrence of stones and biliary stricture, or readmission within 30 days.

LCBDE can be performed either through the cystic duct or through a choledochotomy. Recently, some studies have shown high success rates with the transcystic approach [37, 38]. However, the transcystic approach is limited by the location, size, number of stones and diameter of the cystic duct [29]. In our series, most patients presented with multiple, large CBD stones. In addition, our experience with LCBDE through the cystic duct is limited, but the anterior incision of the CBD is a skilled operation, which can reduce the operation time and the risk of the procedure during the acute cholangitis stage. Thus, our surgeons performed LCBDE via choledochotomy with primary closure for the treatment of acute cholangitis caused by common bile duct stones.

Bile leakage negatively influences postoperative recovery and patients might need further interventions or even reoperation. Bile leakage following primary closure is a major criterion for assessing the safety of LCBDE with primary closure for the treatment of CBDS-related cholangitis. In our series, 5 patients (5/193, 2.59%) in the PC group and 3 patients (3/62, 4.84%) in the T-tube group experienced postoperative bile leakage, which is comparable with the bile leakage rates of 2.5–7% reported by other studies [12, 15, 39, 40]. Previous studies have shown that T-tube do not prevent bile leakage [9, 35]. In our study, the presence of the T-tube did not prevent bile leakage, as 3 patients experienced bile leakage when the tube was still in situ. Some studies [14, 15, 18] have shown that surgeon experience and CBD diameter are two important risk factors for bile leakage after primary closure. In our study, LCBDE was performed by surgeons with more than 10 years of experience in hepatobiliary and laparoscopic surgery, and the criteria for primary closure after LCBDE were powerfully executed. In our institution, the indications for primary closure of the CBD incision are as follows: (1) CBD stones with no intrahepatic bile duct stones; (2) CBD diameter greater than 8 mm; (3) no severe edema of the CBD wall; (4) normal function of the Oddi sphincter without residual stones; and (5) no biliary hemorrhage. These criteria are similar to those in previous studies [12, 13, 18, 19].

Retained stones are one of the major complications following LCBDE and have been reported in up to 8.5% of cases [41]. With the application of choledochoscopy and laser lithotripsy equipment, the rate of retained stones has been significantly reduced to approximately 2% [19, 42]. In our series, the rate of retained stones was 2.75% (7/255). This may be due to the use of the choledochoscope and repeated confirmation of duct clearance before duct closure. Retained stones were detected in four patients who underwent LCBDE with primary closure, and the retained stones were removed by ERCP with no additional surgery required.

The recurrence of stones and biliary stricture after LCBDE are rare complications, and a previous long-term study showed that patients with primary closure have low rates of stone recurrence and biliary stricture [43]. In our series, no biliary stricture occurred after LCBDE during a median follow-up of 18 months, which may be due to the strict indications that required patients who underwent LCBDE to have a dilated CBD (≥ 8 mm in diameter). In our study, there was no significant difference between the two groups in stone recurrence rate.

In our series, patients in the PC group who underwent primary duct closure had a significantly shorter operative time and postoperative hospital stay and lower medical expenditure than those who underwent T-tube drainage (P < 0.01). Moreover, the median time until return to work or full physical activity was shorter in the PC group than in the T-tube group (P < 0.01). These results are comparable with those of previous studies [9, 36, 44]. LCBDE with primary closure in patients accelerates hospital discharge and recovery and lessens hospital expenses. In this new era of laparoscopic surgery, therapeutic methods tend to be increasingly minimally invasive, and LCBDE with primary closure is consistent with the concept of reducing trauma, hastening the patient’s recovery, and reducing the need for hospitalization.

Our current study was a retrospective analysis, and all retrospective analyses may have selection bias. Although the two groups did not have significant differences in the demographic data and clinical characteristics of the patients and the comparison of the two groups in terms of morbidity, mortality, operation time, postoperative hospital stay, and hospital expenses was a fair comparison, and the choice to perform either primary closure or T-tube drainage was, to a certain extent, based on our clinical experience. The aim of the present study was to obtain preliminary data to compare primary closure after LCBDE with conventional T-tube drainage, and the non-inferiority of LCBDE with primary closure is an important finding. Large well designed and adequately powered RCTs that compare primary duct closure and T-tube insertion are still required to validate these observations.

In conclusion, LCBDE with primary duct closure is a safe and effective approach for the management of CBDS-related cholangitis, is not inferior to T-tube drainage and has a shorter operative time, and leads to shorter postoperative hospital stays and lower medical expenditures for patients. A randomized clinical trial is needed to further evaluate the benefits of LCBDE with primary closure in this subgroup.