Laparoscopic Bile Duct Surgery: Normal-Sized Ducts May Be as Safe as Dilated Ones for a Novel Stent Technique

A single-center retrospective propensity-matched cohort study suggests that primary closure with a self-disengaging biliary stent during laparoscopic common bile duct exploration may yield comparable perioperative outcomes regardless of bile duct diameter, though the study’s observational design and use of a non-standard, in-house device limit the strength of its conclusions and clinical applicability.

Why This Matters

Common bile duct stones affect millions of patients worldwide, and laparoscopic common bile duct exploration (LCBDE) with primary closure offers a sphincter-preserving alternative to endoscopic sphincterotomy, which carries its own long-term complications. However, many surgeons consider a normal-diameter bile duct a relative contraindication to primary closure because of concerns about postoperative bile leakage in a narrower ductal lumen. If primary closure with an internal stent proves equally safe regardless of duct size, the eligible patient population for this minimally invasive approach could expand meaningfully. The timing of this research matters because interest in single-stage laparoscopic management of cholelithiasis with choledocholithiasis is growing, yet comparative safety data for normal-caliber ducts remain sparse.

Clinical Summary

LCBDE with primary duct closure avoids the morbidity of T-tube drainage and the long-term sphincter dysfunction associated with endoscopic sphincterotomy. A key concern has been whether closing a normal-diameter common bile duct (CBD), defined in this study as 8 mm or less, introduces unacceptable risk of bile leakage compared to closure of a dilated duct. Published in 2025 by Huang and colleagues from Yixing People’s Hospital in Jiangsu, China, this retrospective cohort study examined 343 consecutive patients who underwent LCBDE with primary closure supported by a self-disengaging biliary stent, a device the surgical team fabricated in-house by modifying a 6 French ureteral double-J stent. The stent is designed to migrate spontaneously into the duodenum, eliminating the need for a second procedure for removal.

After propensity score matching produced 114 pairs balanced on nine covariates, the investigators found no statistically significant differences between the normal-diameter and dilated CBD groups in operative time, blood loss, length of hospital stay, hospitalization cost, or complication rates. The overall complication rate was 9.3%, and the bile leakage rate was 7.3% across the full cohort. Multivariate logistic regression identified the Charlson Comorbidity Index (CCI) as the sole independent predictor of postoperative bile leakage (OR 2.587; 95% CI 1.729 to 3.873). The authors acknowledge that the single-center retrospective design, limited sample size for detecting rare events, and the non-standard device preclude definitive conclusions and call for multicenter prospective validation.

Dr. Caplan’s Take

This study addresses a genuine clinical question that matters to patients and surgeons alike: can we safely close a normal-sized bile duct after stone extraction without leaving a T-tube in place? The mechanistic logic of using an internal stent to bridge the early healing period is sound, and the propensity-matched comparison is a reasonable approach given the infeasibility of blinding in this context. But the distance between “encouraging single-center data” and “ready for widespread adoption” is significant. When a patient asks whether this technique is safe for their anatomy, an honest answer requires acknowledging that the device itself is handmade and not commercially available, and that these results come from a highly experienced team working in optimal conditions.

In my practice, I view this as hypothesis-generating evidence that supports continued investigation rather than a mandate to change surgical approach. For patients with choledocholithiasis who are candidates for LCBDE, I discuss the full range of options including endoscopic approaches, T-tube drainage, and primary closure, tailoring the conversation to their comorbidity burden, duct anatomy, and the surgical expertise available at their institution. The CCI finding reinforces what we already know: preoperative comorbidity assessment should drive risk discussions more than duct diameter alone.

Clinical Perspective

This study sits at a relatively early point in the research arc for self-disengaging biliary stents in LCBDE. It adds to a small body of literature, largely from Chinese surgical centers, suggesting that primary closure with internal stenting is feasible across a range of duct diameters. What it confirms is that experienced hands can achieve acceptable complication rates in normal-caliber ducts. What it does not establish is whether these results are transferable to other institutions, other devices, or surgeons with less specialized experience. The exclusion of patients requiring emergency drainage, T-tube conversion, or transcystic exploration means the study population was selected for technical favorability, and the reported complication rates should not be extrapolated to broader surgical populations.

From a safety standpoint, the 7.3% bile leakage rate across the full cohort is not trivial and warrants attention in preoperative counseling. The CCI-driven risk stratification finding is immediately actionable: clinicians should incorporate formal comorbidity scoring into their decision-making for patients being considered for primary closure. There are no drug-interaction considerations specific to this surgical intervention, but the perioperative antibiotic regimen and any anticoagulation management should follow institutional protocols. The single most concrete recommendation a clinician can implement now is to systematically assess CCI in all patients being considered for LCBDE with primary closure and to use elevated comorbidity burden as a trigger for heightened postoperative bile leakage surveillance.

Study at a Glance

What Kind of Evidence Is This

This is a retrospective single-center cohort study employing propensity score matching to compare outcomes between two subgroups defined by common bile duct diameter. It sits in the middle tier of the evidence hierarchy, above case series and uncontrolled observational reports but below prospective cohort studies and randomized controlled trials. The single most important inference constraint is that propensity score matching can only adjust for measured and included confounders, meaning unmeasured differences between groups, such as surgeon judgment, stone characteristics, or intraoperative technical difficulty, may still influence outcomes. This design cannot establish causal equivalence between groups.

How This Fits With the Broader Literature

The concern about primary closure in normal-diameter bile ducts has persisted in hepatobiliary surgery for years, with some groups advocating T-tube drainage or endoscopic approaches as safer defaults. A number of Chinese surgical centers have published case series and small comparative studies supporting primary closure with various internal stent designs, generally reporting acceptable bile leakage rates. This study extends that literature by applying propensity score matching to address baseline differences between duct-diameter groups, a methodological step beyond simple retrospective comparison. However, the broader literature still lacks any multicenter randomized trial comparing primary closure with internal stenting to either T-tube drainage or endoscopic sphincterotomy in normal-caliber ducts, which remains the critical evidence gap.

Common Misreadings

The most likely overinterpretation is concluding that this study proves primary closure with a self-disengaging stent is equally safe in normal and dilated bile ducts and therefore ready for general adoption. The null finding, meaning no statistically significant difference between groups, does not demonstrate equivalence. The study was not designed or powered as a formal non-inferiority trial, so the absence of a difference could reflect insufficient sample size to detect one, particularly for low-frequency complications. Additionally, because the stent is fabricated in-house and not commercially available, replicating this exact intervention at another institution is not straightforward, and assuming equivalent results with different devices would be speculative.

Bottom Line

This study provides cautiously encouraging observational evidence that CBD diameter alone may not determine complication risk after LCBDE with primary closure and an internal stent. It does not establish safety equivalence, and the in-house device limits reproducibility. Its most actionable contribution is the identification of CCI as an independent predictor of bile leakage, reinforcing the clinical priority of formal comorbidity assessment before selecting patients for this approach. Multicenter prospective validation is needed before practice change.