Cholecystectomy or gallbladder in situ after endoscopic sphincterotomy and bile duct stone removal in Chinese patients. Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial. Elective cholecystectomy without drainage and without prophylactic antibiotics. A prospective randomized trial with clinical and bacteriological aspects. Laparoscopic common bile duct exploration and cholecystectomy versus endoscopic stone extraction and laparoscopic cholecystectomy for choledocholithiasis. A prospective randomized study. A controlled trial of drainage after cholecystectomy. A randomized study of cholecystectomy with and without drainage. Choledocholithiasis. Endoscopic sphincterotomy or common bile duct exploration. Evaluation of the role of prophylactic antibiotics in elective laparoscopic cholecystectomy: a prospective randomized trial. Long-term follow-up of a prospective randomized study of endoscopic versus surgical treatment of bile duct calculi in patients with gallbladder in situ.
In patients with stones in their bile ducts and gallbladders, cholecystectomy is generally recommended after endoscopic sphincterotomy and clearance of bile duct stones. However, only approximately 10% of patients with gallbladders left in situ will return with further biliary complications. Expectant management is alternately advocated. In this study, we compared the treatment strategies of laparoscopic cholecystectomy and gallbladders left in situ.
                We randomized patients (>60 years of age) after endoscopic sphincterotomy and clearance of their bile duct stones to receive early laparoscopic cholecystectomy or expectant management. The primary outcome was further biliary complications. Other outcome measures included adverse events after cholecystectomy and late deaths from all causes.
                One hundred seventy-eight patients entered into the trial (89 in each group); 82 of 89 patients who were randomized to receive laparoscopic cholecystectomy underwent the procedure. Conversion to open surgery was needed in 16 of 82 patients (20%). Postoperative complications occurred in 8 patients (9%). Analysis was by intention to treat. With a median follow-up of approximately 5 years, 6 patients (7%) in the cholecystectomy group returned with further biliary events (cholangitis, n = 5; biliary pain, n = 1). Among those with gallbladders in situ, 21 (24%) returned with further biliary events (cholangitis, n = 13; acute cholecystitis, n = 5; biliary pain, n = 2; and jaundice, n = 1; log rank, P = .001). Late deaths were similar between groups (cholecystectomy, n = 19; gallbladder in situ, n = 11; P = .12).
                In the Chinese, cholecystectomy after endoscopic treatment of bile duct stones reduces recurrent biliary events and should be recommended. Patients who undergo endoscopic sphincterotomy for common bile-duct stones, who have residual gallbladder stones, are referred for laparoscopic cholecystectomy. However, only 10% of patients who do not have this operation are reported to develop recurrent biliary symptoms. We aimed to assess whether a wait-and-see policy is justified.
                We did a prospective, randomised, multicentre trial in 120 patients (age 18-80 years) who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones. Patients were randomly allocated to wait and see (n=64) or laparoscopic cholecystectomy (56). Primary outcome was recurrence of at least one biliary event during 2-year follow-up, and secondary outcomes were complications of cholecystectomy and quality of life. Analysis was by intention to treat.
                12 patients were lost to follow-up immediately. Of 59 patients allocated to wait and see, 27 (47%) had recurrent biliary symptoms compared with one (2%) of 49 patients after laparoscopic cholecystectomy (relative risk 22.42, 95% CI 3.16-159.14, p<0.0001). 22 (81%) of 27 patients underwent cholecystectomy, mainly for biliary pain (n=13) or acute cholecystitis (7). Conversion rate to open surgery was 55% in patients allocated to wait and see who underwent cholecystectomy compared with 23% in those who were allocated laparoscopic cholecystectomy (p=0.0104). Morbidity was 32% versus 14% (p=0.1048), and median hospital stay was 9 versus 7 days. Quality of life returned to normal within 3 months after either treatment policy.
                A wait-and-see policy after endoscopic sphincterotomy in combined cholecystodocholithiasis cannot be recommended as standard treatment, since 47% of expectantly managed patients developed at least one recurrent biliary event and 37% needed cholecystectomy. No major biliary complications arose, but conversion rate was high. A consecutive series of 50 patients undergoing elective cholecystectomy without prophylactic antibiotics entered a prospective randomized trial to compare the post-operative clinical course whether the subhepatic space was drained or not. 26 patients (mean age 58 yrs) were drained and 24 patients (mean age 59 yrs) were not. The incidence of positive gallbladder bile cultures were respectively 8 and 19% (N.S.) in the drained and undrained groups. The incidence of post-operative mortality, thrombo-phlebitis and intra-abdominal sepsis was zero in both groups. In the drained or undrained series, the incidence of wound infection was respectively 4% and 0% (N.S.), that of urinary infection was 8% and 13% (N.S.) and that of pulmonary atelectasis was 15 and 17% (N.S.). A further consecutive series of 100 undrained elective cholecystectomies (18% positive bile cultures) without prophylactic antibiotics was then performed with the same uneventful postoperative course. This study therefore indicates that even in the presence of bacterobilia elective cholecystectomy can be safely performed without subhepatic space drainage and without prophylactic antibiotics. Our objective is to compare the results of laparoscopic cholecystectomy (LC) and common bile duct (CBD) exploration to those of endoscopic stone extraction and LC in patients with CBD lithiasis based on a prospective randomized study.
                From April 1997 until August 2000, 78 patients were assigned in two groups. Group A (n'36) patients underwent laparoscopic either direct or trancystic duct, CBD exploration and LC. Group B (n'42) patients were referred for endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (ES) for duct clearance and at a later stage LC was performed. Selection of patients of both groups was done, considering prognostic factors of a preliminary study.
                Laparoscopic duct clearance was achieved in 85.7% of patients while the respective percentage for the combined approach was 84.3%.
                Laparoscopic CBD exploration is not yet established as the gold standard procedure for choledocholithiasis and there is the need for further randomized trials and possibly future meta-analyses. A prospective controlled trial of drainage after cholecystectomy has been carried out. In a consecutive series of 143 patients undergoing cholecystectomy, 50 patients were randomly allocated to a drainage group and a further 50 patients to a non-drainage group. The remaining 43 patients were drained electively because the common bile duct was explored or because of infection or incomplete haemostasis. There was no significant difference in the incidence of wound infection or other complications between the drainage and the non-drainage groups. The duration of postoperative pyrexia, the number of analgesic injections and the length of postoperative hospital stay were the same in both the randomized groups. One patient in the randomized drainage group had a reactionary haemorrhage from the drain site requiring transfusion. There was no mortality but one patient in the elective drainage group had to be re-explored for a subhepatic abscess. Three patients in this group drained bile from the drain for 3-9 days but all had a T tube in place. This trial fails to demonstrate any advantage or disadvantage in draining the gallbladder bed after cholecystectomy. Routine drainage of the bed of the gallbladder following cholecystectomy remains controversial. A prospectively randomized series of 100 instances of cholecystectomy for chronic and subsiding acute cholecystitis are reviewed. Postoperative fever was lowered, the need for dressing changes was virtually eliminated and hospital stay was shortened in patients who did not undergo drainage. No complications attributable to drain avoidance were seen. A prospective randomized trial was conducted of preoperative endoscopic sphincterotomy and surgery (ES&S) or surgery alone (SA) in 52 patients with cholecystolithiasis and choledocholithiasis that were candidates for elective surgery. After ES&S 65% of patients were stone free. Eighty-eight per cent of patients with SA were stone free after surgery (p less than 0.05). Three patients in each group had residual stones at the completion of the operation. Five of these six had more than 20 common bile duct (CBD) stones. There was one episode of major hemorrhage in a patient in each group and no deaths. Costs were essentially equal for the individual patient with a successful ES as compared to SA. Societal costs of a program of preoperative endoscopic retrograde cholangiopancreatography and ES would be higher because of the cost of screening for patients with CBD stones. These results do not support preoperative ES as a technique for clearance of the CBD of stones on the basis of efficacy, morbidity rate, or cost. At present the use of prophylactic antibiotics in elective laparoscopic cholecystectomy is controversial. This prospective study was carried out to define the role of prophylactic antibiotics in elective laparoscopic cholecystectomy to prevent postoperative infection. Ninety three patients were randomly placed in two groups. Group A comprised of 40 while group B consisted of 53 patients. Patients in Group A received 1.5 grams of second generation cephalosporin (cefuroxime sodium) diluted in 100ml of normal saline, at the time of induction of anesthesia. Group B patients received an equal volume of normal saline only. A sample of gall bladder bile was collected by direct gall bladder puncture intra-operatively for aerobic and anaerobic culture. Age, sex, weight of the patient, American Society of Anesthesiologists classification grade, presence of diabetes mellitus, episodes of colic 30 days preceding surgery, intra-operative gall bladder rupture, stone and / or bile spillage, results of bile culture, gall bladder histology, length of hospital stay, and number of septic complications were recorded and analyzed. In group A, one patient (2.5%) had post operative wound infection and in group B, two patients (3.8%) had post operative infection which was statistically similar (p>0.1). There was no difference between the two groups in terms of demographic, intra operative and post operative denominators. Therefore the study concluded that prophylactic antibiotics did not have a significant role to play in prevention of postoperative wound infection in elective laparoscopic cholecystectomy. Eighty-three patients with bile duct calculi were entered in a prospective randomized study of endoscopic sphincterotomy (ES) and stone removal (group 1) versus surgery alone (group 2), and were followed for more than 5 years. In group 1 endoscopic stone clearance was successful in 35 of 39 patients. Thirteen patients subsequently had cholecystectomy with (n = 7) or without (n = 6) biliary symptoms and one had a cholecystostomy for acute cholecystitis. Two patients have had mild biliary colic or pancreatitis. Two patients died from gallbladder carcinoma after 9 days and 18 months. In group 2 bile duct stones were cleared surgically in 37 of 41 patients. Late complications occurred in two patients (incisional hernia and recurrent stone). One patient with gallbladder carcinoma was cured and another died after 16 months. Early major and minor complications occurred in three and four respectively of 39 patients in group 1, and in three and six respectively of 41 patients in group 2. There were no deaths. During follow-up the total morbidity rate reached 28 percent (11 of 39) and 5 percent (two of 41) (P = 0.005) and the non-biliary related mortality rate was 31 percent (12 of 39) and 10 percent (four of 41) (P = 0.02) in groups 1 and 2 respectively. Nine patients in group 1 and two in group 2 died from heart disease (P = 0.02). Total hospital stay was 2-42 (median 13) days and 6-36 (median 16) days in groups 1 and 2 respectively (P not significant). Endoscopic and surgical treatment of bile duct calculi in middle-aged and elderly patients with gallbladder in situ are equally effective in the long term. However, the significantly increased mortality rate from heart disease in patients treated endoscopically compared with those treated surgically might speak in favour of operation.
Prophylactic cholecystectomy should be offered to patients whose gallbladders remain in-situ after endoscopic sphincterotomy and common bile duct clearance.