Choledocholithiasis is the presence of stones within the common bile duct (CBD)¹ Gallstones are prevalent in approximately 15% population of the United States².Although figures quoted vary according to the age, sex, and ethnicity of the group examined, the overall prevalence in India is almost similar^3,4.Choledocholithiasis is classified as primary or secondary according to stone origin. Primary choledocholithiasis refers to stones formed directly within the biliary tree, while secondary choledocholithiasis refers to stones ejected from the gallbladder. Primary choledocholithiasis generally composed of brown stones, associated with bacterial infection of the bile duct. Bacteria secrete an enzyme that hydrolyzes bilirubin glucuronides to form free bilirubin, which then precipitates^5-7. Secondary choledocholithiasis stone composition parallels that of cholelithiasis, with cholesterol as the most common type. Stones typically originate in the gallbladder then migrate to the common bile duct.  In distinction to cholelithiasis, the majority of choledocholithiasis is symptomatic specifically, right upper quadrant pain, caused by distention of the extrahepatic bile duct, along with nausea and vomiting⁸.Biliary stones are classified by chemical composition: cholesterol (>70% cholesterol), mixed (30% < cholesterol < 70%), and pigmented (cholesterol < 30%)⁹.

The diagnosis of choledocholithiasis is initially suggested by symptomatology, laboratory tests, and ultrasound (US) findings. Individually, each of these variables has a poor sensitivity and specificity for choledocholithiasis^10,11.Nearly 55% of patients with common bile duct stones have symptoms and half of them have complications¹². Recommended treatment strategies for common bile duct stones are preoperative endoscopic retrograde cholagio pancreaticography (ERCP) followed by cholecystectomy, cholecystectomy with intraoperative cholan- giography, intraoperative ERCP, surgical removal of the stone, postoperative ERCP^13-15. Amongst all, preoperative ERCP and laparoscopic cholecystectomy (LC) is the most preferred approach these days due to the development of expertise over time and technical availability at most centers^16,17.ERCP procedures, which include bile duct cannulation, contrast infusion, and sphincterotomy, may induce inflammation that could impact the outcomes of subsequent laparoscopic cholecystectomy (LC) by causing intraoperative difficulties and postoperative complications. However, the advantage of performing LC early (24 to 72 hours after ERCP) versus late (>6 weeks) remains uncertain. This study aims to compare these two timing approaches in terms of intraoperative challenges, operative time, drain use, conversion rates to open surgery, postoperative complications, and hospital stay duration. Therapeutic strategies for managing choledocholithiasis often include preoperative ERCP followed by LC, LC with intraoperative laparoscopic CBD exploration, LC with intraoperative ERCP (rendezvous technique), or LC with postoperative ERCP.

AIM

To compare the clinical outcome following early and late cholecystectomy patients after ERCP

The study was a hospital-based comparative analysis conducted over a 10-month period at the Department of Surgery, S.P. Medical College and P.B.M Hospital in Bikaner. It aimed to evaluate outcomes in patients undergoing early versus late cholecystectomy following endoscopic retrograde cholangiopancreatography (ERCP). All post-ERCP patients who presented to the Surgery Department during the study period and met the inclusion criteria were included. The sample size was calculated with a 95% confidence interval, based on a previous study reporting a mean interval to operation of 33.74 ± 13.64 hours. To ensure adequate power with a 10% allowable error, the minimum sample size was calculated to be 78, rounded up to 80.The study included patients aged 18 years or older who had undergone successful endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (ES) and stone extraction for choledocholithiasis, and who had radiologically confirmed residual gallbladder stones. Eligible patients had either undergone ERCP for choledocholithiasis within the last 72 hours or had undergone the procedure six weeks or more prior to the study. Additionally, participants had to be deemed medically and mentally fit to undergo cholecystectomy.Patients were excluded if they were younger than 18 years, unfit for general anesthesia, or had severe malnutrition, a history of cholecystectomy, liver cirrhosis, or altered anatomy such as Roux-en-Y gastric bypass. Also excluded were those who had undergone ERCP for conditions other than common bile duct stone (CBDS) management, or who had a failed ERCP requiring biliary stent placement. Patients with cholecystitis, peritonitis, pancreatitis, cholangitis, or those unwilling to participate in the study were also excluded.

Table-1: Distribution of both group according to their age (years)

In group A maximum 45.00% were observed in 21-40 years whereas minimum were 2.5% in up to 20 years age group. In group B maximum 42.5% were observed in 21 – 40 year and 46-60 years whereas minimum were 2.5% in up to 20 years age group. Mean age in group A was 43.15±10.5 years whereas 43.80± 9.25 years in group B. (p>0.05)  Fig:Distribution of both groups according to their Socioeconomic status (B G PRASAD)

In group A maximum 52.5% were observed in class IV whereas minimum 5.00% were in class II. In group B maximum 50.00% were observed in class IV whereas minimum 5.00% in class II. (p>0.05) 

Table-2: Distribution of both groups according to their method of extraction of stones in ERCP

In group A 60% ERCP was done by EST/Basket/Balloon sweep and in 40% by EST/Basket whereas in group B 65.00% ERCP was done by EST/Basket/Balloon sweep and in 35% by EST/Basket.

Table-3: Distribution of cases of both groups according to intra op difficulty

Out of 40 subjects, intraoperative difficulties were seen in 2 (5%) patients in early LC group while in 9 (22.5%) patients of late LC group. This difference was found statistically significant (p value =0.049).

Table 4: Type of Intraoperative difficulties in early and late LC group

Gall bladder bed bleeding was seen in 1 (2.5%) patients during early LC and in 4 (10%) patients in late LC group. In early LC group, adhesions in Calot‟s triangle was found in 2 (5%) patients compared to group B where 7(17.5%) patients were having adhesion. Other intra-operative difficulties seen in late LC group were bile leakage (n=1; 2.5%) and Difficulty in dissecting Calot‟s triangle which was seen in 2 and 3 patient in both groups respectively.

Table-5: Distribution of cases of both group according to their post operative complication

In group A no post op complication was seen whereas in group B, maximum 5% had complaint of significant drain output followed by 2.5% had wound site infection was found. The difference was statistically significant. (p=0.049*)

Table 6:Comparison of Mean hospital stay (days) between early and late LC groups

In group A maximum 80.00% had 1 to 2 days of hospital stay whereas minimum 20% had 0 to 1 days. In group B maximum 85% had hospital stay of >2 days whereas minimum 15% had 1-2 days of stay.  Mean duration in group A was 1.95± 0.45 days whereas 3.75±0.56 day in group B. (p<0.05) 

In our study, in group A maximum 45.00% were observed in 21-40 years whereas minimum were 2.5% in up to 20 years age group. In group B maximum 42.5% were observed in 21 – 40 year and 46-60 years whereas minimum were 2.5% in up to 20 years age group. Mean age in group A was 43.15±10.5 years whereas 43.80± 9.25 years in group B. In group A 62.5% were male whereas 65% in group B.  Maximum 67.5% were rural in group A whereas 75% rural in group B. In A group maximum 52.5% were observed in class IV whereas minimum 5.00% were in class II. In group B maximum 50.00% were observed in class IV whereas minimum 5.00% in class II. Thus we know that in our study both groups were comparable in terms of socio- demography.  Similarly Apoorv Goel et al (2021)¹⁸ found that a total of 89 patients were enrolled in this study, of which 71 females and 18 males were there. Mean age was 45 ± 1.23 and 43 ± 0.93 in group I and group II, respectively. There was no significant difference in BMI and other comorbid conditions in both the groups.

Patients in whom there was intermediate likelihood of CBD Stones underwent MRCP and the presence of CBD Stones was confirmed. ERCP was    then        planned.  

In            group     A            60%       ERCP     was done  by EST/Basket/Balloon sweep and in 40% by EST/Basket whereas in group B 65.00% ERCP was done by EST/Basket/Balloon sweep and in 35% by EST/Basket. Similarly Salman B et al¹⁹ and Ibrahim ZH et al²⁰ also achieved 100% clearance rate of CBD after ERCP without major complications.

In our study, out of 40 subjects, intraoperative difficulties were seen in 2 (5%) patients in early LC group while in 9 (22.5%) patients of late LC group. This difference was found statistically significant (p value =0.049). Gall bladder bed bleeding was seen in 1 (2.5%) patients during early LC and in 4 (10%) patients in late LC group. In early LC group, adhesions in Calot‟s triangle was found in 2 (5%) patients compared to group B where 7 (17.5%) patients were having adhesion. Other intra operative difficulties seen in late LC group were bile leakage (n=1; 2.5%) and Difficulty in dissecting Calot‟s triangle which was seen in 2 and 3 patient in both groups respectively. Similarly Mathur A et al. (2021)²¹ found that out of 35 subjects, intraoperative difculties were seen in 2 (5.7%) in early LC group, these included adhesions and edema, and GB bed bleed;10 (28.6%) patients of late LC. (p value =0.02).  El Nakeeb A et al²² found that no significant difference was observed between both groups as regards the conversion rate, the degree of adhesion,

In our study, in group A no post op complication was seen whereas in group B, maximum 5% had complaint of significant drain output followed by 2.5% had wound site infection. The difference was statistically significant. (p=0.049*) Similarly Ghnnam WM et al. (2016)²³ observed that only five patients had complications in the form of biliary leak from cystic duct stump in two cases one from each group, one postoperative bleeding (group II only) and two wound infection in group II only. Also Rajesh K. Patel et al 2019²¹ that the postoperative complication rates were 10%(2/20) in Group ELC and 30%(6/20). In Group DLC 4 patient wound infection whereas. In group ELC only 2 patients had wound infection.

In our study, in A group maximum 80.00% had 1 to 2 days of hospital stay whereas minimum 20% had 0 to 1 days. In B group maximum 85% had hospital stay of >2 days whereas minimum 15% had 1-2 days of stay.

Mean duration in A group was 1.95± 0.45 days whereas 3.75±0.56 day in B group. (p<0.05). Similarly   Mathur A et al. (2021)²⁴ The mean hospital stay (in days) in early LC group (Group A) patients  was 1.91±0.81 which was signi cantly lesser compare to late LC  group (Group B) patients in which mean hospital stay was 2.60±1.12  days. (p value <0.01). Also Ghnnam WM et al. (2016)²³ Mean hospital stay was shorter in group I (4.1 days), rather than (6.1 days) in group II (P =0.023). Our study was in line with Rajesh K. Patel et al 2019²¹ found that the mean Post operative hospital stay in their study in Group ELC were 3 days and in Group DLC 5.7 days and it was also significant at p<0.01 level.

Based on the results achieved in the present study early laparoscopic cholecystectomy after ERCP in the patients of cholelithiasis with coexisting choledocholithiasis was found to be safe. Therefore, we hereby conclude that early laparoscopic cholecystectomy after Endoscopic Retrograde Cholangiopancreaticography (ERCP) is better as compared to late laparoscopic cholecystectomy after ERCP in patients of cholelithiasis with coexisting choledocholithiasis. So, we recommend performing early Laparoscopic Cholecystectomy after ERCP.

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