Preoperative external biliary drainage in obstructive jaundice. A prospective controlled clinical trial. Usefulness of percutaneous transhepatic biliary drainage in patients with surgical jaundice--a prospective randomised study. Preoperative endoscopic drainage for malignant obstructive jaundice. Preoperative biliary drainage for cancer of the head of the pancreas. [Routine drainage following uncomplicated, elective cholecystectomy? A prospective, randomized study]. A controlled trial of drainage after cholecystectomy. Pre-operative percutaneous transhepatic biliary drainage: the results of a controlled trial. Cholecystectomy is safer without drainage: the results of a prospective, randomized clinical trial. Evaluation of preoperative biliary drainage in the surgical management of pancreatic head carcinoma.
57 patients with obstructive jaundice were randomly allocated to surgery with preoperative external biliary drainage (29 patients) and without preoperative external biliary drainage (28 patients). 22 patients ultimately underwent laparotomy after a mean of 11.7 days of drainage and 25 had surgery without preoperative drainage. The postoperative complication rate was low and similar in both groups but complications associated with the drainage procedure were substantial. Perioperative mortality was 4/28 (14%) in the drainage group and 4/27 (15%) in the non-drainage group. There seems to be no advantage associated with routine preoperative external biliary drainage before surgery for obstructive jaundice. Patients with obstructive jaundice undergoing surgical procedures have a significant risk of morbidity and mortality. The role of preoperative percutaneous transhepatic biliary drainage (PTBD) was evaluated in a randomized trial.
                A total of 40 patients were assigned to either preoperative PTBD (n = 20), or surgery alone (n = 20). PTBD was performed under ultrasound guidance. There were no major complications related to the procedure.
                Ultrasound guided drainage was a successful and safe method of preoperative biliary decompression. There was a marked relief from pruritus and significant reduction of hyperbilirubinaemia from a mean of 386.48 mumol/L to 116.10 mumol/L (p < 0.001). Mean duration of drainage was 42.5 days. Postoperative complications occurred in five patients in PTBD group (25%) compared to 11 patients (55%) in the control group. One death (5%) occurred in PTBD group compared to four deaths (20%) in the control group (significant at 5% level with probability 0.2).
                Ultrasound guided drainage is a useful preoperative supportive measure in preparing deeply jaundiced patients for surgery and permits hepatic function to return to a near normal state preoperatively. The improved results in our study were due to longer duration of drainage. The role of preoperative endoscopic drainage for patients with malignant obstructive jaundice was evaluated in a randomized controlled trial. A total of 87 patients were assigned to either early elective surgery (44 patients) or endoscopic biliary drainage followed by exploration (43). Thirty-seven patients underwent successful stent insertion and 25 had effective biliary drainage. Complications related to endoscopy occurred in 12 patients. After endoscopic drainage significant reductions of hyperbilirubinaemia, indocyanine green retention and serum albumin concentration were observed. Patients with hilar lesions had a significantly higher incidence of cholangitis and failed endoscopic drainage after stent placement. The overall morbidity rate (18 patients versus 16) and mortality rate (six patients in each group) were similar in the two treatment arms irrespective of the level of biliary obstruction. Despite the improvement of liver function, routine application of endoscopic drainage had no demonstrable benefit. Endoscopic drainage is indicated only when early surgery is not feasible, especially for patients with distal obstruction. The benefits of preoperative biliary drainage, which was introduced to improve the postoperative outcome in patients with obstructive jaundice caused by a tumor of the pancreatic head, are unclear.
                In this multicenter, randomized trial, we compared preoperative biliary drainage with surgery alone for patients with cancer of the pancreatic head. Patients with obstructive jaundice and a bilirubin level of 40 to 250 micromol per liter (2.3 to 14.6 mg per deciliter) were randomly assigned to undergo either preoperative biliary drainage for 4 to 6 weeks, followed by surgery, or surgery alone within 1 week after diagnosis. Preoperative biliary drainage was attempted primarily with the placement of an endoprosthesis by means of endoscopic retrograde cholangiopancreatography. The primary outcome was the rate of serious complications within 120 days after randomization.
                We enrolled 202 patients; 96 were assigned to undergo early surgery and 106 to undergo preoperative biliary drainage; 6 patients were excluded from the analysis. The rates of serious complications were 39% (37 patients) in the early-surgery group and 74% (75 patients) in the biliary-drainage group (relative risk in the early-surgery group, 0.54; 95% confidence interval [CI], 0.41 to 0.71; P<0.001). Preoperative biliary drainage was successful in 96 patients (94%) after one or more attempts, with complications in 47 patients (46%). Surgery-related complications occurred in 35 patients (37%) in the early-surgery group and in 48 patients (47%) in the biliary-drainage group (relative risk, 0.79; 95% CI, 0.57 to 1.11; P=0.14). Mortality and the length of hospital stay did not differ significantly between the two groups.
                Routine preoperative biliary drainage in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. (Current Controlled Trials number, ISRCTN31939699.)
                2010 Massachusetts Medical Society A prospective randomized and controlled study of prophylactic drainage after simple, elective cholecystectomy was carried out. From March 1988 to June 1991 80 patients received an Easy-Flow drain and 80 did not. Operation and perioperative management were standardized. The endpoint of the study was postoperative morbidity, especially postoperative pyrexia and subhepatic fluid collection. The latter was identified by ultrasonography performed daily on postoperative day 1-4. No patient died. The morbidity including postoperative pyrexia revealed no difference between drained and undrained patients. In 19 of the patients with (23.8%) and in 25 of the patients without drainage (31.3%) a subhepatic fluid collection could be demonstrated by ultrasonography. This difference was not statistically significant either. We conclude that prophylactic drainage after elective, simple cholecystectomy is of no use for the patient. As subhepatic fluid collections can be seen in drained as well as in undrained patients it has to be accepted that drainage does not guarantee the removal of subhepatic fluid. Therefore its indicatory function (bleeding) and the ability to prevent the patient having biliary peritonitis or local abscess has to be put in doubt. 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. The operative mortality for biliary tract obstruction due to malignancy is high. In 1981 a controlled clinical trial of pre-operative percutaneous drainage was started at the Royal Postgraduate Medical School. At the time of percutaneous transhepatic cholangiography patients were randomized either to laparotomy or to pre-operative percutaneous transhepatic biliary drainage ( PTBD ) followed by laparotomy. Only patients with malignant biliary tract obstruction and serum bilirubin greater than 100 mumol/l were included. Seventy patients entered the trial, and five were withdrawn. Of the 65 remaining, 31 underwent laparotomy and 34 had pre-operative PTBD followed by laparotomy. The median duration of drainage was 18 days and during this time the median bilirubin fell from 305 to 115 mumol/l. Five patients required early surgery for complications of PTBD and two died within 30 days of surgery. The mortality for laparotomy was 19 per cent (6/31) compared with 32 per cent (11/34) for drainage plus laparotomy. This trial highlights the hazards of PTBD in high risk patients and has failed to demonstrate a reduction in mortality with the use of pre-operative PTBD . Drainage after cholecystectomy remains routine despite the lack of scientific supportive data. Numerous clinical studies in the past have attempted to address this controversy but have failed to resolve the issue for different reasons. These include retrospective design, inclusion of only selected cases, and randomization before surgery. In this study 479 patients undergoing cholecystectomy were randomly allocated to a drainage group (a high-pressure suction drain in Morison's pouch for 48 hours) or a nondrainage group. Randomization was performed at the time of peritoneal closure. All patients undergoing cholecystectomy, both elective and urgent, were included and the operations were performed by all grades of surgeons. There were two deaths from cardiopulmonary causes, both in the drainage group. No patient required reoperation in either group. The incidence of both wound infections (15 vs 5; p less than 0.05) and chest infections (56 vs 19, p less than 0.02) was significantly higher in the drainage group. Three hundred fifty-six patients underwent abdominal ultrasonography 72 hours after surgery. The number of subhepatic fluid collections thus detected was significantly higher in the patients who received a drain (17 vs 6, p less than 0.05). None of these collections was clinically significant. The postoperative hospital stay was longer in the patients with drains (10.3 vs 9.1 days), but this difference failed to reach statistical significance. We conclude from this study that the use of a drain after cholecystectomy serves no useful purpose and is potentially harmful. This practice should be abandoned. In a consecutive series of 38 patients, resectional surgery was performed for carcinoma of the caput pancreatis (ampullary, distal common bile duct and pancreatic duct). In group A (n = 19), preoperative biliary drainage was accomplished via an endoprosthesis introduced during endoscopic retrograde cholangiopancreatography. Group B (n = 19) had no preoperative biliary drainage. The interval from admission to operation averaged 15 days in group A and 4 days in group B. Two group B patients died of causes unrelated to absence of preoperative biliary drainage. In group B, however, the intrabiliary pressure was higher than in group A and was associated with heightened incidence of biliary infection, bacteremia and intraoperative bleeding. The intergroup difference in incidence of early complications was statistically significant. The findings support the value of preoperative biliary drainage in patients who are candidates for surgical treatment of carcinoma of the pancreatic head.
There is currently not sufficient evidence to support or refute routine pre-operative biliary drainage for patients with obstructive jaundice. Pre-operative biliary drainage may increase the rate of serious adverse events. So, the safety of routine pre-operative biliary drainage has not been established. Pre-operative biliary drainage should not be used in patients undergoing surgery for obstructive jaundice outside randomised clinical trials.