Comparison of long-term results of laparoscopic and endoscopic exploration of common bile duct

Background: To compare long term results of laparoscopic and endoscopic exploration of common bile duct, to assess post-procedure quality of life. Materials and Methods: From September 1992 to August 2003, we performed 4058 cholecystectomies, out of which 479 (11.80%) patients had choledocholithiasis. There were 163 males and 316 females. Mean age was 63.65 ± 5.5 years. These patients were put in two groups. In the first group of 240 patients, a majority of patients underwent two-stage procedures. ERCP/ES was performed in 210 (87.50%) cases. In the second group of 239 patients, a majority of patients underwent single-stage procedures. ERCP/ES was done in 32 (13.38%) cases. Results: Mortality was zero in both groups. Morbidity was 15.1% in first group and 7.5% in second group. Mean hospital stay was 11.7 ± 3.2 days in first group and 6.2 ± 2.1 days in second group. Average operative time was 95.6 ± 20 minutes in first group and 128.4 ± 32 minutes in second group. Completed questionnaires received from 400 (83.50%) patients revealed better long-term results in the second group. Clinical features of low-grade cholangitis were seen in 20% of patients who underwent ES. Hence the postprocedure quality of life in patients who underwent single-stage procedures was definitely much better, because of minimal damage of sphincter of Oddi. Conclusions: Single-stage laparoscopic operations provide better results and shorter hospital stay. Damage to sphincter of Oddi should be minimal, to avoid long-term low-grade cholangitis. In young patients, the operation of choice should be singlestage laparoscopic procedure with absolutely no damage to sphincter of Oddi.

The management of common bile duct stones (CBDS) remains controversial.There is no standard algorithm and the disparity in laparoscopic skills among surgeons has perpetuated this lack of a standard. [1]his situation is reflected in practices and studies that describe either a complete reliance on endoscopic retrograde cholangiopancreatography (ERCP), or persistent common practice of open common bile duct exploration (CBDE) for management of choledocholithiasis. [2,3] The current options available for the management of choledocholithisis at the time of LC, include pre-operative ERCP and ES, intra operative ERCP, post-operative ERCP, laparoscopic transcystic common bile duct exploration (LTCCBDE), laparoscopic choledochotomy and LCBDE and open bile duct exploration.In our clinic, we use a balanced approach to the management of the choledocholithiasis.

MATERIALS AND METHODS
From September 1992 to August 2003, 4058 LC were performed in our clinic.2678 (65.99%) patients were operated for chronic cholecystitis and 1380 (34%) for acute cholecystitis.There were 2962 (72.99%) women and 1086 (26.76%) men.The mean age of the patients was 54.8 years (range 5-84 years).29% of patients were classified as high-risk ASA III-IV.Pre-operative examination was done through medical history, biochemical tests and ultrasonography in all patients.10% patients had CT and MRI examination before operation.
During the period 1992 through 1997, in the patients with clinical features of choledocholithiasis, the first step was ERCP.If ERCP confirmed CBDS, we performed endoscopic sphincterotomy (ES).In the cases of suspected CBDS during LC, the diameter of CBD was measured with a special instrument.If it was > 8 mm and cystic duct was > 4 mm, intra-operative cholangiography (IOC) was indicated.LTCCBDE was attempted, if CBDS were confirmed.
During the second phase from 1997 to 2003, most patients were treated by laparoscopic procedures.If there was a high suspicion of choledocholithiasis in a patient with significant co-morbidities, a pre operative ERCP and ES was performed followed by LC.Otherwise, LC was done straight-away.In the cases of choledocholithiasis, we tried to perform LTCCBDE or choledochotomy and LCBDE.Post-operative ERCP was used, if these methods of treatment of choledocholithiasis were incomplete.Open CBDE was reserved for those cases that failed to respond to the minimally invasive maneuvers.

Technique
ERCP was performed by standard techniques.Laparoscopic IOC was performed by inserting a standard cholangio-catheter into a nick in cystic duct.LTCCBDE was performed after initially evaluating the characteristics of cystic duct, CBD and stones.This procedure was often facilitated by balloon dilatation of cystic duct,and augmented by use of wire baskets, balloon catheters, choledochoscopy and electrohydraulic lithotripsy (EHL).For a few relatively small stones, a spiral basket was passed fluoroscopically for stone retrieval.If these measures failed clearing the duct, choledochoscopy was performed.We utilized a 3.4 mm outer diameter choledochoscope with a 3.6 Fr inner channel (Karl Storz Endoscopy), or used a 2.7 mm outer diameter Olympus choledochoscope.The choledochoscope was used to guide basket retrieval, or to assess the success of other maneuvers.For large or impacted stones, EHL through choledochoscope was used for fragmentation.The particles were then either retrieved transcystically, or flushed through the ampulla.If the anatomy was unfavorable for transcystic approach, or if there were too many stones (>5) and CBD was of sufficient size, a choledochotomy and LCBDE were performed.If there were stones 5-7 mm in diameter and stenosis of papilla, an intra-operative ES and balloon stone extractions were performed.In some patients, we performed post-operative ERCP and ES for clearing CBD.In presence of cholangitis, we used a T-tube or transcystic drainage.In other cases, we closed choledochotomy using a biliary stent.The patients were followed up in the out-patient clinic at a 3-6 months interval.

RESULTS
The chi-square test and Fisher's exact test were used for analysis of data.ES was attempted in 202 patients and succeeded in 182 (90.09%) patients.32 patients had large stones, which were crushed and a Fogarty catheter was used to wash them out.In 5 patients, it was impossible to retrieve the large stones.Of the 9 patients in whom no duct clearance was obtained, 4 underwent open cholecystectomy with CBDE and 5 patients had successful LCBDE.ERCP/ES-related complications occurred in 20 (10.9%) patients.In 10 (5.5%) patients, bleeding occurred, necessitating a laparotomy in 2 patients and prolonged hospital stay with transfusion in 12 patients.6 (3.3%) patients developed post-procedure pancreatitis.Cholangitis and sepsis were seen in 3 patients (1.6%) and these patients under went laparotomy.Open CBDE with T-tube drains was performed.1 patient suffered duodenal perforation and this patient required laparotomy.
Amongst patients in whom ERCP/ES was performed before LC, there were some further complications; raising the number to 25    A careful analysis of table 2 reveals that the frequency of symptoms associated with low grade cholangitis were less in the second group (P<0.05), the explanation is less damage to the sphincter of Oddi.

DISCUSSION
One stage operations have some benefits, as compared to two stage operations.Morbidity after one-stage operations was only 7.5% (2 times lower), in our series.6][7][8][9][10] Cuschieri et al [11] reported a prospective randomized multi-center trial, showing similar success and complication rates and a significant reduction of hospital stay for single stage management of choledocholithiasis.Furthermore, it is shown that particularly patients with ASA stage I and II benefit from simultaneous laparoscopic surgery and that high-risk patients should undergo primary ES.
According to a recent publication, LCBDE can also be conducted safely with a low complication rate in older patients. [12]We had a similar experience with our therapeutic concept.Obtaining definitive stone retrieval (after transcystic approach, success was obtained in 72% after laparoscopic choledochotomy, successful retrieval of stones was 94%).We have a complication rate of 7.5%, which interestingly is two times lower than after two-stage operations.Our data is comparable with data reported in literature. [1,4,6,9,11,13]Advantageous impact on shorter hospital stay was observed in our series.Hospital stay was 12.7 ± 3.8 days after two-stage operations and 7.2 ± 2.1 days after a one-stage operation.We prefer a single-stage procedure.
Although some authors have suggested primary closure of the choledochotomy without drainage, [14] we believe that for the safety of the patient, bile duct decompression must be achieved.Despite of its advantages, T-tube has significant complications such as post-operative bacteremia, stone formation around the tube, skin excoriations at the exit site, prolonged biliary fistula, retention of a fragment of the tube, late bile duct stricture and dislodgement of the tube with subsequent bile peritonitis and sepsis leading to mortality. [11,15,16]19] All forms of external biliary drainage should be avoided in the ideal single stage procedure for sake of the patient's comfort.Although the use of modified biliary stent obviates the discomfort and complications associated with an external drainage tube, it also has some disadvantages.With this approach, cholangiogram is not feasible, no fistulous tract is available for removal of retained stones and endoscopic removal of stent is sometimes necessary.In our option, the benefits of the stent out weigh the disadvantages.
Controversy still exists concerning impaired function of the papilla following ES.Soehendra et al, [3] reports absence of papilla function impairment.In contrast, other groups report reflux of duodenal secretion into bile ducts and presence of bacteria in the biliary ductal system in 70% of cases [20][21][22] and significant biliary symptomatology in 15% of patients. [17,23,24]Tranter and Thompson reported a late development of bile duct cancer in upto 2% of patients following ES, possibly based on the chronic mucosal inflammation. [25]In contrast, LCBDE provides the anatomical and functional integrity of the papilla.
Clearly there is no single best approach for the management of choledocholithiasis.The optimal treatment is one that can be performed in the same setting as LC, while maintaining a minimal invasive approach.LTCCBDE meets these requirements with the lowest rate of morbidity, but admittedly it is not always possible, or successful.Laparoscopic choledochotomy has proven to be safe and successful, but it is appropriate only when less invasive means have failed or are expected to fail and the duct is of appropriate size.ERCP/ES is useful as a primary treatment in the group of patients with jaundice and severe co-morbidities.ERCP/ES can also be a good option for the post-operative management of retained stones, but it should not be relied upon routinely in lieu of intra-operative management.Most cases of choledocholithiasis can be managed at the time of LC.This approach decreases the patient's hospital stay and the overall cost of treatment.

CONCLUSIONS
1.While selecting the operative technique to treat choledocholithiasis, single-stage procedures should be given the priority, as they cause less morbidity and short hospital stay.2. Damage to sphincter of Oddi should be minimal to obtain better long-term results.3. Consideration of post-procedure quality of life should be given high priority.4. In young patients, laparoscopic single-stage procedures should be used to extract stones and the sphincter of Oddi should not be cut.
(13.73%)patients; in 20 patients after ES and in 5 patients during LC.Conversion to open procedure was done in 8 patients due to technical difficulties, Mirizzi syndrome and incomplete clearance of CBD.IOC during LC in 40 patients in the first group detected CBDS.LTCCBDE was successfully performed in 12 patients.The remaining 28 patients underwent post operative ES, with clearance of CBD.Complications occurred in 4 patients in whom ES was performed after LC.Acute pancreatitis: 2, bleeding: 1 and duodenal perforation: 1 (this patient underwent laparotomy).

Table 1 : Comparison of results of treatment of the two groups of the patients with choledocholithiasis
Recurrent cholangitis was detected only in 6 (3.94%) patients.2 (1.31%) patients revealed residual stones and in 2 (1.31%) patients, recurrent stones were detected.In all of these patients, ES was carried out and good results were obtained.