Common bile duct stones occur in 5% of asymptomatic and 10-20% of symptomatic gallstone patients, necessitating treatment to prevent complications like obstructive jaundice and pancreatitis. 

Options include open and laparoscopic common bile duct exploration, as well as endoscopic retrograde cholangiopancreatography, with laparoscopic techniques gaining popularity due to advancements in instrumentation¹.Open common bile duct exploration (CBDE) remains vital in situations where ERCP or laparoscopic methods fail. Stones can be accessed via the cystic duct or direct choledochotomy, with the latter preferred for larger stones or complex anatomy. The closure of the choledochotomy is crucial, utilizing techniques like T-tube drainage, primary duct closure, or repair over an antegrade biliary stent, each with unique management needs and associated risks². Laparoscopic common bile duct exploration (LCBD) can be performed either trans-cystically or via direct choledochotomy. The choice of approach depends on factors such as the size, quantity, and distribution of the stones, as well as the diameter of the cystic duct³. When direct choledochotomy is indicated to clear the stone burden, it is managed either by primary duct closure (PDC) or by closure with T-tube drainage (TTD). TTD was commonly used in open CBD exploration and has remained a standard practice after laparoscopic common bile duct exploration (LCBDE) to provide postoperative decompression of the common bile duct and allow visualisation of the biliary system through cholangiography to check for residual stones⁴. T-tube drainage (TTD) carries significant complications, such as drain site pain and biliary leaks, affecting about 15% of patients, along with longer hospital stays and increased costs. As a result, many surgeons advocate for primary closure of the common bile duct to reduce T-tube-related issues and facilitate quicker recovery. Internal biliary stenting methods, including antegrade stents, have proven effective and safe, offering shorter hospital stays and faster returns to normal activities compared to TTD⁵ . While internal biliary stenting can lead to complications in about 10% of patients, T-tube drainage (TTD) remains traditional due to its advantages, including CBD decompression and stone extraction⁶. Primary duct closure (PDC) offers a promising alternative by reducing complications and hospital stays, but it carries risks such as bile leaks and CBD strictures due to inadequate expansion⁷.

To minimize complications related to both TTD and PDC, antegrade biliary stent (ABS) placement has been used. ABS is an effective and safe technique that prevents TTD-related complications while reducing biliary pressure without causing bile loss. However, biliary stents also have potential complications, including clogging, pancreatitis, proximal or distal migration, cholangitis, and perforation^2.

AIM

To study safety and clinical efficacy of:  Billiary Stent and T-tube Biliary drainage in patients of choledocholithiasis.

The study is a hospital-based prospective comparative study designed as a randomized control trial, conducted at SMS Medical College and Hospital in Jaipur. The study duration extended from the approval of the Review Board and Ethical Committee until the desired number of cases was achieved. The study population comprised patients clinically diagnosed with choledocholithiasis who were undergoing open common bile duct exploration. A total of 80 cases meeting the inclusion criteria were randomly selected for the study. Inclusion criteria encompassed patients of ASA grade I and II undergoing elective open choledocholithotomy, those who had failed ERCP, individuals aged 18 to 80, and patients who provided informed consent. Conversely, patients were excluded if they had a history of previous choledocholithotomy, a deranged coagulation profile, or any other contraindications.

Table 1: Age distribution of study subjects

Among 80 patients mean age was 52 .12 years, maximum patients were from age group 41-60 years i.e. 38.75% followed by age group 61-80 years in which 32.5 % cases are present.

Table 2 : Duration of surgeryTable 4 : Duration of postoperative stay (days)

The mean duration of surgery was significantly shorter in the biliary stent group (60.82 minutes) compared to the T-Tube group (90.32 minutes), with a p-value less than 0.05. Additionally, the mean postoperative hospital stay was reduced to 3.35 days for the biliary stent group, compared to 5.6 days for the T-Tube group, alongside significantly lower intraoperative blood loss in the biliary stent group (10.95 ml vs. 32.30 ml).

Graph: Surgical site Wound infectionTable 8 : Biliary peritonitis after T –tube removal

In the T-Tube group, 4% of cases retained bile duct stones, while no stones were retained in the biliary stent group. However, this difference was not statistically significant, with a p > 0.05.One patient in the T-Tube group (2.5%) developed biliary peritonitis afterT-tube removal, which was managed conservatively.

Table 3: ReadmissionTable 14: Reoperation

One patient (2.5%) with a biliary stent and six patients (15%) in the T-tube group were readmitted to the hospital. In the T-tube group, readmissions occurred because four patients had retained CBD stones, one had a wound infection, and one had biliary peritonitis. Meanwhile, in the biliary stent group, patients were readmitted due to wound infections.One patient was re-operated in tube T group while no one is operated in biliary stent group.

Table 4: VAS

The VAS scores were significantly lower in the biliary stent group compared to the T-tube group from postoperative day 1 to day 7, with a p-value less than 0.05.

In our study of 80 patients, the mean age was 52.12 years. Most patients (38.75%) were aged 41-60, followed by 32.5 % aged 61-80. The mean surgery duration was 90.32 minutes for the T-Tube group and 60.82 minutes for the biliary stent group, significantly shorter for the latter (p < 0.05).

The mean duration of postoperative hospital stay was 5.6 days for the T-Tube group and 3.35 days for the biliary stent group. The postoperative stay was significantly shorter in the biliary stent group, with a p-value less than 0.05. While study by Sinha et al.⁸, shows larger duration of postoperative hospital stay was 6 days for the biliary stent group, significantly shorter than the 9.5 days for the T-tube group. In contrast, Perez et al. ⁹ found a shorter hospital stay for the biliary stent group, but it was not statistically significant compared to the T-tube group. Another study by Saeed N et al. ¹⁰ reported a mean postoperative hospital stay of 13.6 days for the T-tube group after open CBD exploration. T-tube drainage requires more nursing care, which is important considering hospital bed shortages and rising costs.

In our study, the mean intraoperative blood loss was 32.30 ml for the T-Tube group and 10.95 ml for the biliary stent group, demonstrating significantly less blood loss in the biliary stent group (p < 0.05). This finding is consistent with Yakun Xu et al.,¹¹ who also reported significantly lower intraoperative blood loss in the stent drainage group compared to the T-tube drainage group (P < 0.05).Surgical site wound infections occurred in 37.5% of the T-Tube group compared to 12.5% in the biliary stent group, a statistically significant difference (p < 0.05). One patient in the T-Tube group (2.5%) developed biliary peritonitis after T-tube removal, which was managed conservatively. No other serious postoperative complications, such as biliary stent retention/migration or intra-abdominal abscess, were observed during the study patient (2.5%) with a biliary stent and six patients (15%) in the T-tube group were readmitted to the hospital. In the T-tube group, readmissions occurred because four patients had retained CBD stones, one had a wound infection, and one had biliary peritonitis. Conversely, patients in the biliary stent group were readmitted due to wound infections. Additionally, one patient underwent reoperation in the T-tube group, whereas no patients required reoperation in the biliary stent group.Sinha et al also reported that only One patient (4%) in biliary stent and 4 patients (16%) in T tube were readmitted 3 patients (12%) had retained CBD stones in T tube as compared to none in biliary stent group. Perez g et al. ⁹ shows Three patients (7%) with a biliary stent and one patient (3%) with a T-tube were hospitalised. There were no deaths.

In our study, VAS scores from postoperative day 1 to day 7 were significantly lower in the biliary stent group compared to the T-tube group, with a p-value less than 0.05. Sinha et al.⁸ similarly demonstrated a statistically significant difference in postoperative pain between patients undergoing CBD exploration with a biliary stent versus those with a T-tube. Patients in the biliary stent group experienced notably less pain, possibly attributed to the absence of an additional tube in the abdomen, which can contribute to discomfort and complications such as T-tube site and surgical site wound infections

Biliary stenting is a safe and effective with lesser rate of surgical site wound infections, shorter postoperative hospital stays, few readmissions rate and less postoperative discomfort in hospital settings where either laparoscopic CBD exploration facility or expertise are not available.

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