Does Preoperative Percutaneous Biliary Drainage Reduce ... - NCBI

Does Preoperative Percutaneous Biliary Drainage Reduce Operative Risk or Increase Hospital Cost? HENRY A. PITT, M.D., ANTOINETTE S. GOMES, M.D., JUAN F. LOIS, M.D., LINDA L. MANN, R.N., LARRY S. DEUTSCH, M.D., WILLIAM P. LONGMIRE, JR., M.D.

Despite recent advances in perioperative support care, surgery for obstructive jaundice is still associated with significant morbidity and mortality. For this reason, preoperative percutaneous transhepatic drainage (PTD) has been recommended for these patients. This method of management, however, has only been supported by retrospective and nonrandomized studies. Therefore, a prospective, randomized study was performed to determine the effect of preoperative PTD on operative mortality, morbidity, hospital stay, and hospital cost. Thirty-day mortality was 8.1% among 37 patients undergoing preoperative PTD, compared to 5.3% for 38 patients who went to surgery without preoperative drainage. Overall morbidity was also slightly, but not significantly, higher in patients who underwent preoperative PTD (57% versus 53%). However, total hospital stay was significantly longer (p < 0.005) in the PTD group (31.4 days versus 23.1 days). The cost of this excess hospitalization and the PTD procedure at our university medical center was over $8000 per patient. The authors conclude that preoperative PTD does not reduce operative risk but does increase hospital cost and, therefore, should not be performed routinely.

From the Departments of Surgery and Radiology, UCLA School of Medicine, Los Angeles, California, and the Surgical Service, Sepulveda VA Medical Center, Sepulveda, California

cutaneous biliary decompression has not been clearly

established.21-23,25 Therefore, a prospective, randomized study was undertaken to determine: (1) whether preoperative percutaneous biliary drainage reduces the risk of operation for obstructive jaundice and (2) whether this procedure is cost-effective. Methods

URING THE PAST DECADE, numerous studies'-7 have documented that surgery for severe obstructive jaundice is associated with a postoperative mortality of 15-25% and morbidity of 40-60%. Among the factors that have been associated with increased risk following surgery are a bilirubin greater than 10 mg/dL'-5'8-'0 and a number of other risk factors, including advanced age,

malignant obstruction, anemia, leukocytosis, increased creatinine, and hypoalbuminemia. 18-11 Because of the significant risks associated with an operation for biliary tract obstruction, several authors have recommended percutaneous transhepatic biliary drainage for preoperative preparation.2'3'6'7"'7 A number of more recent reports,18-25 however, have cautioned that many patients undergoing percutaneous transhepatic drainage are at risk for both early and late complications. Moreover, some of these authorities have suggested that the potential benefit of preoperative perPresented at the 96th Annual Session of the Southern Surgical

Association, Palm Beach, Florida, December 3-5, 1984. Reprint requests: Henry A Pitt, M.D., 77-130 Center for the Health Sciences, UCLA School of Medicine, Los Angeles, CA 90024. Submitted for publication: December 7, 1984.

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Study Protocol Patients admitted to the UCLA Medical Center and to the Sepulveda Veterans Administration Medical Center, from January 1981 through June 1983, were screened for possible inclusion in the study. Patients were considered eligible for participation if initial work-up (liver function tests, ultrasound, computerized tomography, or previous transhepatic or endoscopic retrograde cholangiography) suggested obstructive jaundice. Additional eligibility requirements included: (1) a bilirubin of 10 mg/dL or higher; (2) five or more risk factors, as previously described by Pitt and others;' and (3) the attending surgeon's judgment that the patient was an operative candidate. Thus, most patients in whom preoperative work-up suggested widespread metastases were excluded by the third eligibility criterion. In general, these patients with end-stage malignancies were managed by percutaneous placement of a transhepatic biliary stent or endoprosthesis and never came to surgery. Using the above criteria, 79 patients were entered into the study (Fig. 1). Seventy-seven of these patients had a bilirubin greater than 10 mg/dL, whereas only two (one in each group) were included in the study because of risk factors alone. From a list of random numbers at each institution, 40 patients were randomized to receive preoperative percutaneous transhepatic drainage (PTD), and 39 were allocated to the group that were

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Patient s Entered 7r9

No PTD

PTD 40

No Surgery 3

Surgery Surgery r

37

39 /jCNo Surgery

I

38

FIG. 1. Outline of preoperative percutaneous transhepatic drainage (PTD) study. Of 79 patients entered, 75 came to surgery and, thus, completed the protocol.

to undergo surgery without preoperative drainage (No PTD). Informed consent was obtained from patients randomized to receive preoperative percutaneous decompression. In these patients, the protocol called for surgery to be postponed until the bilirubin had fallen below 10 mg/dL. In those patients included with five or more risk factors, surgery was delayed until the number of risk factors was brought down below five. This protocol was approved by the Human Subject Protection Committee at the UCLA Medical Center and by the Human Studies Committee at the Sepulveda Veterans Administration Medical Center. Every attempt was made to ensure that supportive care and preoperative preparation, except for biliary drainage, were identical in the two study groups.

Percutaneous Transhepatic Drainage Those patients allocated to the PTD group received broad-spectrum parenteral antibiotics before and for variable periods after percutaneous drainage. The length of antibiotic administration was determined by the degree of fever and/or leukocytosis. In general, antibiotics were continued until the patient was afebrile for at least 24 hours. Biliary decompression catheters were placed under aseptic conditions after patients had received local anesthesia, as well as parenteral sedative and analgesic medications. Transhepatic cholangiography was initially performed with a 21- or 22-gauge Chiba® needle. Once the bile ducts were opacified, biliary drainage was accomTABLE 1. Patient Population

Number of patients

Age, years

Age > 70 years Male Malignant obstruction Anergy Weight loss > 10% Fever > 38 C Bilirubin > 20 mg/dL Risk factors > 4 Risk factors

PTD

No PTD

37 60.9 ± 2.0 22% 54% 78% 70% 46% 24% 27% 35% 3.89 ± .21

38 60.4 ± 2.4 26%

*68%

76% 70% 37% 18% 34% 32% 3.82 ± .20

Ann. Surg. * May 1985

plished via a right lateral or anterior approach with either a Cope catheter system or the Hawkins needle set. In most patients, an 8.3 F Ring catheter was inserted. Rarely, a 6.5 F pigtail catheter was placed initially and later exchanged for an 8.3 F Ring catheter. No concerted effort was made to pass the biliary drainage catheter through the obstructing lesion in these preoperative patients. However, internal drainage was achieved in 32% of the patients who were successfully drained. All catheters were initially placed to a closed external drainage system and were irrigated with sterile saline only if they became obstructed. The external portion of these catheters was occluded only in those patients with internal drainage who remained afebrile off of antibiotics and had satisfactory improvement in their liver function tests. Patient Population Of the 79 patients entered into the study, 75 came to surgery and, thereby, completed the study protocol (Fig. 1). Despite initial plans for surgical exploration in all patients, three patients in the PTD group and one patient in the undrained group never came to surgery. However, none of these four patients suffered significant complications from PTD or his/her other therapy, and all four have survived. Therefore, had these four patients been included in the subsequent analysis, the author's conclusions would not be changed. Of the 75 patients completing the study protocol, 37 were in the PTD group and 38 went to surgery without preoperative PTD. The mean age of patients who underwent preoperative percutaneous transhepatic drainage was almost identical to that of patients who were not drained (Table 1). In addition, the percentage of patients greater than 70 years of age and the percentage of men in each group were not significantly different. Moreover, other factors that may have influenced outcome such as the percentage of patients with malignant obstruction, anergy to common recall antigens, weight loss of more than 10%, fever on admission, a total bilirubin above 20 mg/dL, and those with more than four risk.factors' did not differ between groups. The causes of biliary obstruction in the 75 study patients are presented in Table 2. Seventy-eight per cent of the patients undergoing preoperative percutaneous transhepatic drainage and 76% of the undrained patients had an underlying malignancy. Adenocarcinomas of the pancreas and cholangiocarcinomas were the most commonly encountered malignancy in each group. Common duct stones were the most frequent benign cause of severe biliary obstruction. Admission, preoperative, and postoperative laboratory data for the two study groups are presented in Table 3.

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On admission, laboratory data for the PTD and No PTD groups did not differ significantly, except for the serum glutamic oxaloacetic transaminase (SGOT) levels, which were somewhat higher (p < 0.06) in the No PTD group. As would be expected, preoperative liver function tests were significantly lower in the PTD group. However, preoperative PTD also resulted in significantly lower (p 0.05). Five of the 11 deaths in the PTD group were in patients who never came to surgery. Three other nonrandomized studies with historical controls, on the other hand, have tended to favor preoperative drainage. Takada and his associates from Japan3 reported, in 1976, that operative mortality had been reduced to six per cent from 28% following the introduction of preoperative PTD. Similarly, Nakayama and others2 from another institution in Japan noted, in 1978, that mortality was eight per cent among patients prepared before surgery with PTD, compared with a 28% mortality among historical controls undergoing surgery without PTD. A recent report by Gobien et al.26


from the Medical University of South Carolina noted a mortality of 12% among 25 patients who underwent preoperative PTD from 1980 to 1983, compared to a mortality of 30% among 27 patients who underwent surgery without preoperative PTD from 1977 to 1980. Three additional reports with concurrent, but nonrandomized controls have also favored preoperative drainage. In 1981, Denning and his colleagues6 from Ohio State University reported that operative mortality was 16% among 25 patients undergoing preoperative PTD and 25% in 32 jaundiced controls. This difference was not statistically significant; however, patients who underwent preoperative PTD did have a lower (p < 0.05) incidence of postoperative complications (28% vs. 56%). In 1982 Norlander and others,27 from the Karolinska Hospital in Stockholm, noted an 18% mortality among 44 operated PTD patients and a 33% postoperative mortality in 42 control patients (p > 0.05). In 1984 Gundry and his associates,7 from the University of Michigan, reported a four per cent postoperative mortality and eight per cent morbidity in 25 PTD patients, compared to a 20% mortality and 52% morbidity in undrained controls. Both improvements with PTD were statistically significant (p < 0.05); however, in this study and in the report by Denning et al.6, the complications following the percutaneous drainage procedure were not included in overall morbidity. The discrepancy between the findings of the three prospective, randomized, controlled studies and the six nonrandomized studies remains somewhat inexplicable. One obvious problem with the historically controlled studies2'3'26 is that many factors, such as an improved awareness of the importance of nutrition, may have changed over time and may have resulted in improved survival during the more recent periods when preoperative PTD was being routinely employed. Moreover, multiple problems with bias and patient selection in nonrandomized studies may affect conclusions. For example, in two of the randomized series the success of PTD was only 87% and 89%, which is similar to the efficiency recently reported by others. '924'25'28'29 However, in the three nonrandomized studies with concurrent controls,6726 no mention is made of any drainage failures among a total of 94 reported patients. Were these highrisk patients excluded from these analyses or included with the undrained patients or were there really no PTD failures? One other possible explanation for the disparate conclusions drawn from the randomized and nonrandomized studies may be differences in study design. For example, were the patients comparable, the PTD technique and management similar, and the length of preoperative drainage the same? The answer to these first two possibilities may be difficult to ascertain, although review of the manuscripts does not reveal any obvious differences

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in patient selection or PTD technique among the studies. Data on the length of preoperative drainage is more straightforward and was 1 1, 1 1, and 18 days in the three randomized studies, compared to 9 and 13 days in the two nonrandomized studies6'7 reporting this information. One reason that preoperative PTD failed to benefit severely jaundiced patients in the randomized studies may be that the length of drainage (11-18 days) was not long enough. Koyama and his associates30 from Japan have shown that both ketogenesis and hepatic mitochondrial respiratory function are impaired with biliary obstruction. These investigators have demonstrated that these processes may take six weeks or more to improve following relief of obstruction. Moreover, other investigators31'33 have documented depressed cellmediated immunity, impaired hepatic reticuloendothelial function, altered lymphocyte transformation, and high levels of circulating endotoxin in patients with obstructive jaundice. To expect these hepatic, immune, and metabolic functions to improve in 11 to 18 days may be unrealistic. Another criticism of the three randomized studies is that the number of patients (55, 65, and 75) may have been too small to demonstrate any difference between groups. However, the number of patients in these series was equal to or larger than in the nonrandomized studies,6'7 which showed an advantage for preoperative PTD. McPherson et al.23 calculated that 45 patients per group would be necessary to demonstrate a decrease in operative mortality from 20% to five per cent with preoperative PTD with a Type I error of five per cent and a Type II error of 40%. Each of the randomized trials, however, had fewer than 90 patients. Nevertheless, Hatfield et al.21 found no difference between groups after 55 patients with a control mortality of 15%. McPherson et al.23 reported a higher mortality for preoperative PTD (32%) with a control mortality of 19%. This trend was also apparent in the present study, which demonstrated a mortality of only five per cent in patients who went to surgery without preoperative PTD. The extremely low overall mortality (6.7%) reported in this series of 75 patients may be explained by a number of factors. First, the operations were performed by a small number of surgeons with considerable experience in hepatobiliary surgery. Moreover, most patients in whom initial work-up demonstrated widespread, advanced malignancies were treated with "palliative" PTD or an endoprosthesis and were never entered into this study. During this same time period, 44 patients were managed in this fashion, and the 30-day mortality in these patients who never came to surgery was 24%. Other recent analyses of palliative PTD report similar20 or higher' 11526 30-day hospital mortality for patients with advanced malignant neoplasms. The authors conclude, therefore, that palliative PTD may not benefit

25% to 30% of patients with advanced malignancy and that routine preoperative PTD cannot be recommended.

References 1. Pitt HA, Cameron JL, Postier RG, Gadacz TR. Factors affecting mortality in biliary tract surgery. Am J Surg 1981; 141:66-72. 2. Nakayama T, Ikeda A, Okuda K. Percutaneous transhepatic drainage of the biliary tract. Gastroenterology 1978; 74:554559. 3. Takada T, Hanyu F, Kobayashi S, Uchida Y. Percutaneous transhepatic cholangial drainage: direct approach under fluoroscopic control. J Surg Oncol 1976; 8:83-97. 4. Braasch JW, Gray BN. Considerations that lower pancreatoduodenectomy mortality. Am J Surg 1977; 133:480-484. 5. Brooks JR, Culebras JM. Cancer of the pancreas: palliative operation, Whipple procedure or total pancreatectomy. Am J Surg 1976; 131:516-520. 6. Denning DA, Ellison EC, Carey LC. Preoperative percutaneous transhepatic biliary decompression lowers operative morbidity in patients with obstructive jaundice. Am J Surg 1981; 141: 61-65. 7. Gundry SR, Strodel WE, Knol JA, et al. Efficacy of preoperative biliary tract decompression in patients with obstructive jaundice. Arch Surg 1984; 119:703-708. 8. Blamey SL, Fearon KCH, Gilmour WH, et al. Predictors of risk in biliary surgery. Br J Surg 1983; 70:535-539. 9. Dixon JM, Armstrong CP, Duffy SW, Davies GC. Factors affecting morbidity and mortality after surgery for obstructive jaundice: a review of 373 patients. Gut 1983; 24:845-852. 10. Hunt DR. The identification of risk factors and their application to the management of obstructive jaundice. Aust N Zeal J Surg 1980; 50:476-480. 11. Bonnel D, Ferrucci, Jr, JT, Mueller PR, et al. Surgical and radiological decompression in malignant biliary obstruction: a retrospective study using multivariate risk factor analysis. Radiology 1984; 152:347-351. 12. Pollock TW, Ring ER, Oleaga JA, et al. Percutaneous decompression of benign and malignant biliary obstruction. Arch Surg 1979; 114:148-151. 13. Smale BF, Ring EJ, Freiman DB, et al. Successful long-term percutaneous decompression of the biliary tract. Am J Surg 1981; 141:73-76. 14. Dooley JS, Dick R, Olney J, Sherlock S. Non-surgical treatment of biliary obstruction. Lancet 1979; 11: 1040-1044. 15. Ferrucci, Jr, JT, Mueller PR, Harbin WP. Percutaneous transhepatic biliary drainage. Radiology 1980; 135:1-13. 16. Hansson JA, Hoevels J, Simert G, et al. Clinical aspects of nonsurgical percutaneous transhepatic bile drainage in obstructive lesions of the extrahepatic bile ducts. Ann Surg 1979; 189: 58-61. 17. Tylen U, Hoevels J, Vang J. Percutaneous transhepatic cholangiography with external drainage of obstructive biliary lesions. Surg Gynecol Obstet 1977; 144:13-18. 18. Berquist TH, May GR, Johnson CM, et al. Percutaneous biliary decompression: internal and external drainage in 50 patients. Am J Radiol 1981; 136:901-906. 19. Carrasco CH, Zornoza J, Bechtel WJ. Malignant biliary obstruction: complications of percutaneous biliary drainage. Radiology 1984; 152:343-346. 20. Clark RA, Mitchell SE, Colley DP, Alexander E. Percutaneous catheter biliary decompression. Am J Radiol 1981; 137:503509. 21. Hatfield ARW, Tobas R, Terblanche J, et al. Preoperative external biliary drainage in obstructive jaundice: a prospective controlled clinical trial. Lancet 1982; II:896-899. 22. McPherson GAD, Benjamin IS, Habib NA, et al. Percutaneous transhepatic drainage in obstructive jaundice: advantages and problems. Br J Surg 1982; 62:261-264. 23. McPherson GAD, Benjamin IS, Hodgson HJF, et al. Preoperative percutaneous transhepatic biliary drainage: the results of a controlled trial. Br J Surg 1984; 71:371-375. 24. Mueller PR, Van Sonnenberg E, Ferrucci, Jr, JT. Percutaneous

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27. 28. 29.

biliary drainage: technical and catheter-related problems in 200 procedures. Am J Radiol 1982; 138:17-23. Stambuk EC, Pitt HA, Osher Pais S, et al. Percutaneous transhepatic drainage: risks and benefits. Arch Surg 1983; 118:1388-1394. Gobien RP, Stanley JH, Soucek CD, et al. Routine preoperative biliary drainage: effect on management of obstructive jaundice. Radiology 1984; 152:353-356. Norlander A, Kalin B, Sundblad R. Effect of percutaneous transhepatic drainage upon liver function and postoperative mortality. Surg Gynecol Obstet 1982; 155:161-166. Leung JWC, Emery R, Cotton PB, et al. Management of malignant obstructive jaundice at The Middlesex Hospital. Br J Surg 1983; 70:584-586. Nilsson U, Evander A, Ihse I, et al. Percutaneous transhepatic cholangiography and drainage: risks and complications. Acta Radiol 1983; 24:433-439.

DISCUSSION DR. JOHN L. CAMERON (Baltimore, Maryland): I would like to commend the authors on this outstanding study that I think is important for several reasons. First, there have been at least a dozen retrospective or uncontrolled prospective studies over the past several years evaluating this same question-whether or not it is important (in terms of postoperative morbidity and mortality) to reduce the serum bilirubin below 10 mg/ dl. One of these studies was carried out by Dr. Pitt and myself in Baltimore; most of these studies have strongly suggested that patients should be decompressed before surgery. This study, the third of three prospective, randomized studies that have been carried out evaluating this question, has conclusively demonstrated that there is no benefit in preoperative decompression carried out routinely in all patients who are to be operated upon with marked hyperbilirubinemia. Secondly, I think the study is important because it certainly is the largest, best controlled, and best carried out of the prospective randomized studies, and I think that we now have to accept the fact that, as much sense as it makes, routine preoperative decompression is not indicated. I would like to ask the authors whether or not, within their group of 75 patients, they were able to identify subgroups who might benefit from a period of preoperative decompression. For instance, in patients with marked hyperbilirubinemia-say, over 20 mg/dl-did those patients benefit by having their bilirubins reduced before surgery? We have demonstrated that patients presenting with sepsis benefit by having percutaneous decompression for at least a several-day period prior to undergoing surgical intervention. Is sepsis an indication, along with marked hyperbilirubinemia, for preoperative decompression? Were there any subgroups that appeared to benefit, even though the overall group did not? (Slide) Have the authors found any benefit in percutaneously placed stents preoperatively in the technical management of the patient at the time of surgery? In two instances, in patients with Klatskin tumors and in patients with sclerosing cholangitis, our experience has been that the placement before surgery of Ring catheters bilaterally has been of great aid technically at the time of surgery. As Dr. Longmire demonstrated years ago, the access to the porta hepatis is greatly increased by mobilizing the gallbaldder; also, by dividing the common duct distally and reflecting it up in the cephalad direction, this area is exposed more readily. However, it still is a difficult area to dissect, and having Ring catheters in place in both the left and right intrahepatic ducts is a great aid in dissecting this area out. One can palpate for normal duct up in the porta hepatis on the left and on the right, and this makes the determination of whether or not the tumor is resectable much easier. Routinely, for Klatskin tumors we place bilateral stents preoperatively, not for decompression, but as a technical aid at the time of surgery. (Slide) The next slide demonstrates another benefit of having a Ring catheter in place before surgery. Once the Klatskin tumor is resected, one can suture the stent-actually, the silastic stent that will be used for the reconstruction-to either end of the Ring catheter, and then


30. Koyama K, Takagi Y, Ito K, Sato T. Experimental and clinical studies on the effect of biliary drainage in obstructive jaundice. Am J Surg 1981; 142:293-299. 31. Fargion SR, Podda M, Cappellini MD, et al. Immunita cellular nelle colestasi intra- ed extra-epatiche. Minerva Dietaol Gastroenterol 1976; 22:261-265. 32. Gianni L, DiPadova F, Zuin M, Podda M. Bile acid-induced inhibition of the lymphoproliferative response to phytohemagglutinin and pokeweed mitogen: an in vitro study. Gastroenterol 1980; 78:231-235. 33. Hunt DR, Allison MEM, Prentice CRM, Blumgart LH. Endotoxemia, disturbance of coagulation, and obstructive jaundice. Am J Surg 1982; 144:325-329. 34. Grace PA, Pitt HA, Lois JF, et al. Risks of percutaneous transhepatic drainage in patients with cholangitis. (Submitted for publication).

draw it down, thereby very accurately and easily placing the stent for the reconstruction. The second disease in which we have found the preoperative placement of stents valuable is sclerosing cholangitis. For the last 4 years, we have been treating sclerosing cholangitis by excising the entire extrahepatic biliary tree, and then dilating up the right and left intrahepatic system as well. This can be done very readily by suturing successively larger-size, tapered, soft catheters, such as a coude catheter, to the end of the Ring catheter, and then pulling them up through the right and left intrahepatic biliary tree, thus dilating these severely strictured ducts. I would like to ask the authors if they have had similar experience of finding Ring catheters of technical aid at the time of surgery. Once again, I would like to congratulate Dr. Longmire and Dr. Pitt on a very important study. DR. J. PHILLIP SANDBLOM (Lausanne, Switzerland): The incidence of complications after therapeutic and diagnostic procedures on the liver and the biliary tract has increased considerably during later years. The proportion of iatrogenic hemorrhage has, in fact, increased threefold during the last 10 years. The main sequel of the hemorrhage concerns blood loss in major hemobilia and clot formation in minor hemobilia. This latter complication is sometimes misinterpreted, as in a case we had recently. (Slide) We introduced a catheter transhepatically into the right hepatic duct, whereupon the cholangiogram showed a defect in the lower part of the common duct, which naturally was thought to be a stone. It was operated on, and the resident, who did not know much about hemobilia, called it "inspissated bile." There is no doubt that this was a clot, especially since the next cholangiogram 1 week later (slide) shows the cause of the hemorrhage, the lesion in the left hepatic duct. Those lesions are frequent because the ducts and the arteries are so close together in Glisson's capsule. One of the great values of a careful and expert prospective study, as this one from Dr. Longmire and his group, is that it puts into place and degrades a procedure that seems indicated from a theoretical point of view but with drawbacks in practice. I have, in fact, always thought it would be of great value to relieve the biliary tract in obstructive jaundice before operation. I am really thankful and happy that I now know better, and I think I am an example of the fact that the older one grows, the more one gets to know.

DR. G. RAINEY WILLIAMS (Oklahoma City, Oklahoma): Over a period of years, Dr. Longmire and co-workers have made extremely important contributions to the surgery of the biliary system. I consider this another contribution. Like others, we had hoped that transhepatic drainage would help preoperative patients, and have used it with anecdotal success. Dr. Longmire and Dr. Pitt have shown very conclusively that the current techniques are not helpful and should not be used. Like Dr. Cameron, I would like to mention another use of transhepatic tubes that on occasion may be important. We recently saw a young woman whose difficulty began, as it so often does, with cholecystectomy. The gallbladder was described by an experienced surgeon as intrahepatic, and the procedure was said to be difficult. She ended up with total