| Background and Objection:cholangiolithiasis is one of the hepatobiliary surgery frequently-occurring disease and common disease. The incidence of cholangiolithiasis is a growing trend with people living environment and diet structure changing, the growth of the population aging, and such as ultrasound, CT, MRI and MRCP imaging diagnostic level unceasing enhancement. At present domestic incidence of cholangiolithiasis is10.0%, and the foreign coverages are up to10.0%-33.0%. Cholelithiasis account for79.9%of the national cholangiolithiasis, and choledocholithiasis is associated with symptomatic gallstones in10.0%-18.0%of cases. According to the site of the stones, cholangiolithiasis is divided into:Cholelithiasis, intrahepatic bile duct stone and extrahepatic bile duct stones. These stones occur either singly or the two sites concurrently, or three sites concurrently at the same time. About20%to40%of the patients with cholelithiasis had no symptoms in their lifetime, which were called static gall bladder calculi.Most patients with gallbladder stones are usually combined with symptoms of chronic cholecystitis, such as indigestion, upper abdominal discomfort and so on. Patients have biliary colic, fever, vomiting and other symptoms when acute inflammations occur. Long-term chronic stimulation and chronic inflammation of bile duct result in the formation of the bile duct carcinoma. cholangiolithiasis lead to acute inflammation, acute suppurative obstructive cholangitis and even endanger the patient’s lives. The patients have shock and death, and these would seriously influence people’s health and daily life. Traditional open cholecystectomy, open common bile duct exploration and T tube drainage is classic operation in management of the gallbladder and extrahepatic bile duct stones for one hundred years. Although its credible effect, wide indications, not being affected by multiple biliary tract surgery, but it exists some defects such as large trauma, more complications, long hospitalization time,sufferings,longer treatment cycle. Its status is gradually being substituted by some minimally invasive surgery in recent years. With the rapid development of modern minimally invasive technology and quick update of medical equipment, endoscopy and laparoscope technique have been widely used in minimally invasive surgery, especially the use of laparoscope and duodenoscope, and the treatment pattern of concomitant cholelithiasis and choledocholithiasis also showed a trend of diversity. The main techniques are as follows at present:①Traditional open cholecystectomy, choledocholithotomy, T-tube drainage;②Laparoscopic combined with intraoperative choledochoscope: laparoscopic cholecystectomy/laparoscopic common bile duct exploration+intraoperative choledochoscope;③laparoscope combined with duodenoscope:(three patterns) a preoperative endoscopic retrograde cholangiopancreatography/endoscopic sphincterotomy+laparoscopic cholecystectomy (Pre-ERCP/EST+LC); b intraoperative endoscopic retrograde cholangiopancreatography/endoscopic sphincterotomy+laparoscopic cholecystectomy(IO-ERCP/EST+LC); c postoperative endoscopic retrograde cholangiopancreatography/endoscopic sphincterotomy+laparoscopic cholecystectomy(Post-ERCP/EST+LC). The ideal minimally invasive treatment for concomitant cholelithiasis and choledocholithiasis remains controversial. The controversy mainly focused on whether need to treat extrahepatic bile duct stones found in LC? Is it in one-stage or two-stage management? Which approach is better? The guildline of European association of endoscopic surgery in1998pointed out that extrahepatic bile duct stones found in LC need to manage even without any symptoms. And the concomitant cholelithiasis and choledocholithiasis can be managed in one-stage procedure LC/LCBDE+IOC or two-stage approach Pre/Post-ERCP/EST+LC, as for other diagnostic and therapeutic strategies need further study. The two-stage approach Pre-ERCP/EST+LC, being used daily practice routine for the treatment of concomitant cholelithiasis and choledocholithiasis, has been more widely adopted by laparoscopic surgeons and endoscopic physicians around the world for past30years, treating most of the CBDS, especially applied in high-risk patients with suppurative cholangitis or severe acute pancreatitis and so on. However, the two-stage approach Pre-ERCP/EST+LC need two operations, two anesthesia and long treatment cycle. Base on no consensus in minimally invasive treatment mode, A few reports about one stage management of IO-ERCP/EST+LC and LC/LCBDE+IOC, duodenal papilla cannulation with4%-18%failure rates, and potentially fatal complications such as perforation, bleeding and acute pancreatitis postoperative ERCP, moreover, Operating complex, time-consuming, high technical requirements of LCBDE with a few center implement, so can the laparoscopic approach/laparoscopic-endoscopic approach be safe and effective? Can patients benefit from this minimally invasive treatment mode? The indications for ERCP and EST and the principle of removal stones are worth further research. A retrospective analysis was conducted of the clinical data for the one stage management of patients with concomitant cholelithiasis and choledocholithiasis by laparoscopic-endoscopic approach and laparoscopic approach in order to evaluate the safety and feasibility of one stage treatment of laparoscopic combined with duodenoscope. Based on above mentioned study, a prospective randomized control trial about one-stage vs. two-stage management for concomitant cholelithiasis and choledocholithiasis was conducted to research the safety, feasibility and technical operation points of laparoscopic combined with duodenoscope. We may provide clinically perfect evidence for safety and feasibility of one stage management of concomitant cholelithiasis and choledocholithiasis by means of laparoscope combined with duodenoscope.Methods and materials The first chapterThe clinical data of88patients with concomitant cholelithiasis and choledocholithiasis from June2010to March2013in the Qingyuan People’s Hospital, department of Hepatobiliary Surgery, were retrospectively analyzed, among them,40patients of group A in laparoscopic-endoscopic approach (IO-ERCP/EST+LC) and48patients of group B in laparoscopic approach (LC/LCBDE+IOC). Fasting, skin and other preparation before operation are necessary. Tracheal intubations were given to the two groups of patients. The LC was firstly carried out in three-hole method (or four-hole method) to treat the patients of group A in supine position. Abdominal drainage tube was placed in Winslow hole if necessary according to the situation. And then the patients were transferred from supine position to prone position and removed the stones of extrahepatic duct by ERCP/EST.①Endoscopic papillary columnar balloon dilatation was used when the diameter of extrahepatic bile duct stones<8mm;②Endoscopic sphincterotomy was carried out when the diameter of extrahepatic bile duct stones>8mm;③Endoscopic sphincterotomy and endoscopic papillary columnar balloon dilatation were used when confronted with diverticulum beside the papilla, the papilla in diverticulum, the flat papilla or coagulation disorders. Endoscopic nasobiliary drainage was used routinely when removed the stones of extrahepatic duct. The LC was firstly carried out in patients of group B by using above mentioned methods. The laparoscopic common bile duct exploration in transductal approach or transcystic approach and choledochoscopic common bile duct exploration were also used in this group. The stones of extrahepatic bile duct stones were directly removed when the stones located below the incision. The T drainage tube was routinely placed when confronted with suspicious CBD retained stones, duodenal papillary stenosis, or distal common bile duct stenosis. Abdominal drainage tube was placed in Winslow hole if necessary according to the situation. Indicators related to the operation, calculi residual rate, morbidity, hospital costs and the average days of hospitalization were recorded respectively. The indicators related to the operation, calculi residual rate, morbidity, hospital costs and the average days of hospitalization in two groups were analyzed comparatively. This retrospective analysis was conducted to evaluate the safety and feasibility of one-stage procedure for the treatment of patients with concomitant cholelithiasis and choledocholithiasis.The second chapterSixty consecutive patients with concomitant cholelithiasis and choledocholithiasis from March2011to December2012in the Qingyuan People’s Hospital, department of Hepatobiliary surgery, were randomly divided into two groups according to inclusion standards and eliminate standards preoperatively, group A (30cases) and group B (30cases). Inclusion criteria:①The patients had right upper quadrant pain repeatedly with or without jaundice.②The patients with suspected biochemical test before operation were examined by means of B ultrasound, computed tomography and magnetic resonance cholangiopancreatography. Exclusion criteria:①Patients ages were less than18years or older than80years old.②The maximum diameter of extrahepatic bile duct stones were more than25mm.③Patients contracted acute cholecystitis.④Common bile duct calculi recurrence, Mirrizi syndrome, combined with intrahepatic bile duct stones, biliary tract neoplasms or other neoplasms.⑤previous ERCP attempt; history of upper abdominal surgery or peritonitis incompatible with laparoscopic surgery;⑥Patients with cardiopulmonary diseases cannot tolerate surgery.⑦American Society of Anesthesiologists (ASA) status IV and V.⑧contraindications to surgical and anesthesia.⑨regnancy. Randomization was created by a computer-generated list in blocks. Group A patients were offered the one-stage (IO-ERCP/EST+LC) technique, whereas group B patients received the standard two-staged treatment (Pre-ERCP/EST+LC). All eligible patients were told operation scheme. Written informed surgical and anaesthetic consent were obtained from all patients. Fasting, skin and other preparation before operation are necessary. Tracheal intubations were adopted in two groups of patients. The LC was firstly carried out in three-hole method (or four-hole method) to treat the patients of group A in supine position. Abdominal drainage tube was placed in Winslow hole if necessary according to the situation. And then the patients were transferred from supine position to prone position and removed the stones of extrahepatic duct by ERCP/EST.①Endoscopic papillary columnar balloon dilatation was used when the diameter of extrahepatic bile duct stones<8mm;②Endoscopic sphincterotomy was carried out when the diameter of extrahepatic bile duct stones>8mm;③Endoscopic sphincterotomy and endoscopic papillary columnar balloon dilatation were used when confronted with diverticulum beside the papilla, the papilla in diverticulum, the flat papilla or coagulation disorders. Endoscopic nasobiliary drainage was used routinely when removed the stones of extrahepatic duct. All patients in group B were scheduled for laparoscopic cholecystectomy within2-5d after ERCP. Our primary endpoint was to detect difference in postoperative hospital stay (first operation till discharge) and secondary endpoints were to detect differences in success rate of CBD clearance, morbidity, hospital cost and total hospital stay. Discharge criteria:the patients were mobilized and fed normally without fever and abdominal pain. Blood routine examination, amylase in blood and urine were normal. Extrahepatic bile duct had no imaging findings of residual stones through nose-bile tube radiography after operation. Parameters of postoperative hospital stay, stone-removing rate, morbidity, cost and hospital stay were analysed comparatively. The prospective randomized control trial was conducted to research the safety, feasibility of the combined endoscopic-laparoscopic technique for one-stage treatment of concomitant cholelithiasis and choledocholithiasis.Statistical analysisStatistical Package for the Social Sciences software (SPSS Version13.0) was used for all analysis. Independent-Samples T test was used in continuous variables, and continuous variables were expressed as means±standard deviations(x±s). Chi-squared test (theoretical frequency>5) and Fisher exact test (theoretical frequency<5) were used in categorical variables, and categorical variables were presented as percentages. Significant level a=0.05.All P values were two-sided. Statistical significance was accepted at P<0.05. Results:The first chapterNo statistically significant difference between the two groups was found in terms of age, gender, clinical presentation, liver function, stone characteristics, or ASA classification (P>0.05). The overall surgical success rate of93.2%(82/88) was achieved. The surgical success rate of90%was achieved in group A, and3cases required conversion to LC/LCBDE+IOC because of duodenal papilla cannulation failure,1case to open surgery on account of Calot triangle dense adhesions. The surgical success rate of95.83%(46/48)was achieved in group B, and2cases required conversion to open surgery because of Calot triangle dense adhesions. An overall success rate of CBDS clearance was86.1%(31/36) in the group A compared with a rate of89.13%(41/46) in the group B. These differences was not statistically significan (χ2=0.172, P=0.678). The average operation time and average intraoperative blood loss were132min and45.5ml respectively in group A versus139min and52.07ml respectively in group B. These differences was not statistically significant (t=1.532,1.245, P=0.130,0.2170respectively). Complications during hospitalization occurred in5patients (13.89%) in the group A and5patients (10.87%) in group B, but the difference was not significant (χ2=0.172, P=0.678). The time of postoperative ambulation and exhaust/cacation were14.36±3.43h and27.78±13.36h respectively in group A versus15.05±3.42h and28.83±14.74h respectively in group B, this difference was not statistically significant (t=0.910,0.333, P=0.366,0.740respectively). The duration of average hospital stay in the group A was significantly shorter than that in the group B (4.14±1.89vs5.89±1.85days)(t=4.219, P<0.001), while total cost in group A was significantly higher than that in the group B (24053.63±2286.17vs17483.65±1832.90Y)(t=14.447, P<0.001)The second chapterNo statistically significant difference between the two groups was found in terms of age, gender, liver function, stone characteristics, or ASA classification(P>0.05) The overall surgical success rate of95%(57/60) was achieved. The surgical success rate of90%(27/30) was achieved in group A, and2cases required conversion to LC/LCBDE+IOC because of duodenal papilla cannulation failure,1case to open surgery on account of Calot triangle dense adhesions. The surgical success rate of100%(30/30) was achieved in group B. The overall success rate of CBDS clearance was82.5%(47/57). An overall success rate of CBDS clearance was81.5%(22/27) in the group A compared with a rate of83.3%(25/30) in the group B. This difference was not statistically significant(χ2=0.034, P=0.854).Complications during hospitalization occurred in four patients(14.8%) in the group A and3patients(10.0%) in group B, but the difference was not significant(Fisher, P=0.697). The total cost, average hospital stay, and the duration of postoperative hospital stay in the group A was significantly and respectively shorter than that in the group B (23370.93±1735.79vs28458.8±1874.27Y,3.59±1.78vs5.70±1.91days,2.52±1.67vs4.37±1.52days)(t=10.60,4.288,4.371, respectively, P<0.001all).Conclusion1The combined endoscopic-laparoscopic technique, shortening the length of hospital stay, seems to be a safe and feasible approach for one-stage treatment of concomitant cholelithiasis and choledocholithiasis due to simultaneously complete two different operations,reduce the operation cost and the comparable complication rate.2The laparoscopes combined with intraoperative choledochoscope for one-stage treatment of concomitant cholelithiasis and choledocholithiasis seems to be a low-loss minimally invasive surgery approach. LC/LCBDE+IOC is an alternative when IO-RECP/EST+LC failed to remove bile duct stones. |
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