Clinical Outcome of Internal Stent for Biliary Anastomosis in Liver Transplantation S.W. Jung, D.S. Kim, Y.D. Yu, and S.O. Suh ABSTRACT Background. This study analyzed the incidence and management of biliary complications after liver transplantation (LT) with or without internal stent. Methods. The medical record of all patients who underwent LT and were hospitalized from December 2009 to March 2013 were reviewed. Patients were grouped into 2 groups (internal stent group vs no stent group). Results. There were 29 deceased-donor liver transplantations (58%) and 21 living-donor liver transplantations (42%). There were 2 perioperative mortalities, and those 2 patients were excluded from this study. The overall biliary complication rate was 6.45% in the internal stent group and 17.65% in the no stent group. The rate of anastomotic stricture was 3.23% (n ¼ 1) in the stent group and 11.76% (n ¼ 2) in the no stent group. The rate of bile leak was 3.23% (n ¼ 1) in the stent group and 0% in the no stent group. The rate of biliary obstruction was 0% in the stent group and 5.88% (n ¼ 1) in the no stent group. Conclusions. The overall rate of biliary complications in the internal stent group was lower than in the no stent group, and most of the biliary complications could be treated successfully with endoscopic or radiologic intervention.

L

IVER TRANSPLANTATION (LT) has become a standard medical treatment as a result of many advances in surgical technique, organ preservation, and immunosuppression. Despite this progress, problems of the bile duct remain a significant cause of short-term and long-term morbidity. Biliary complications can extend the hospital stay significantly, and they often require invasive procedures, such as endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography, reoperation, or even retransplantation. Biliary reconstruction is the final step of LT and can be carried out according to 2 main techniques. One is duct-toduct anastomosis (DD), is rapid, simple, and physiologic. The other, Roux-en-Y hepaticojejunostomy (HJ), is used when the former is not feasible for anatomic reasons or for causes related to the underlying hepatobiliary disease. Usually DD has been done over a T-tube. The use of this stent allows monitoring of bile flow and color and easy performance of cholangiography; however, the presence of a T-tube may also lead to specific complications that account for 30% e50% of overall biliary complications [1]. Many authors have published advantages and disadvantages associated with the use of a T-tube. But there were few 0041-1345/14/$esee front matter http://dx.doi.org/10.1016/j.transproceed.2013.12.025 856

studies about internal stent and biliary complication. The aim of the present study was to compare the incidence of biliary complication after biliary reconstruction with or without internal stent in LT. PATIENTS AND METHODS From December 2009 to March 2013, a total of 50 LTs were performed in the Anam Hospital, Korea University Medical Center. To evaluate the clinical outcome of internal stent, the medical record of the 50 patients who had undergone LT were reviewed. Biliary continuity was established by either DD or HJ. In both reconstructions, internal stent was used or not used by the surgeon’s decision. We did not use external stent. For internal stent, smallbore (6e8 french) silastic stent was used. From the Department of Surgery, Korea University College of Medicine, Seoul, Korea. Address reprint requests to Dong-Sik Kim, MD, PhD, Division of Hepatobiliar-Pancreatic Surgery and Liver Transplantation, Department of Surgery, Korea University College of Medicine, Inchon-ro 73, Seongbuk-gu, Seoul, Korea. E-mail: kimds1@ korea.ac.kr ª 2014 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 46, 856e860 (2014)

INTERNAL STENT FOR BILIARY ANASTOMOSIS

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Table 1. Characteristics of Liver Transplant Recipients and Donors Recipient age (y), mean  SD (range) Recipient sex (M/F) Recipient body weight (kg), mean  SD (range) Cause of liver transplantation Hepatitis Berelated cirrhosis Hepatitis Cerelated cirrhosis Fulminant hepatitis Hepatocellular carcinoma Child classification, n (%) A B C MELD score, mean  SD Donor age (y), mean  SD (range) Donor sex (M/F) Graft type, n (%) Whole liver Right lobe Left lobe Number of graft bile duct openings, n (%) 1 2 3 Size of graft bile duct, n (%) 5 mm >5 mm

Internal stent (n ¼ 31)

No stent (n ¼ 17)

P value

52  10.09 (33e70) 20/11 66.06  13.22 (34e97)

51.65  9.19 (34e66) 9/8 65.8  9.34 (50e83)

.22 .41 .32

22 3 2 22

8 0 6 6

.14 .27 .38 .09

6 (19.35%) 10 (32.26%) 15 (48.39%) 17.29  9.71 35.68  13.07 (6e63) 25/6

2 (11.76%) 2 (11.76%) 13 (76.47%) 23.82  11.30 45.94  13.19 (21e71) 12/5

.59 .12 .22 .08 .2 .09

13 (41.94%) 16 (51.61%) 2 (6.45%)

15 (88.24%) 1 (5.88%) 1 (5.88%)

.07 .06 .19

24 (77.42%) 6 (19.35%) 1 (3.23%)

16 (94.12%) 1 (5.88%) 0 (0%)

.12 .08 .2

6 (19.35%) 25 (80.65%)

1 (5.88%) 16 (94.12%)

.15 .2

Abbreviation: MELD, Model for End-Stage Liver Disease.

We grouped all patients into 2 groups. One was the internal stent group, who used internal stent in biliary reconstruction, and the other was the no stent group, who did not use internal stent. Values are presented as mean  SD. Frequencies of qualitative data and the presence of biliary complication in each group were determined using Pearson chi-square test. Comparison of the statistical significance between the 2 groups was performed according to analysis of variance for donor and recipient quantitative data. Results were considered to be significant for P < .05.

RESULTS

There were 29 deceased-donor liver transplantations (58%) and 21 living-donor liver transplantations (42%). All recipients were adults. There were 2 perioperative mortalities, and those 2 patients were excluded from this study. Forty-six of the patients (95.83%) had their initial biliary reconstruction

by DD. Two patients (4.17%) were initially reconstructed with HJ. In 4 patients, 5 cases of biliary complication developed. One patient had 2 different biliary complications. Thirty-one patients (64.58%) had undergone LT with internal stent and 17 (35.42%) without stent. The mean follow-up time was 18.79  10.61 months in the internal stent group and 24.52  13.66 months in the no stent group. Baseline demographic characteristics and disease-related data were similar in the 2 groups (Table 1). There was no difference in intraoperative data between the groups (Table 2). The overall biliary complication rate was 6.45% in the internal stent group and 17.65% in the no stent group. In the internal stent group, there were 2 biliary complications. One was bile leak, and the other was anastomotic stricture. The time intervals during which bile leak and anastomotic

Table 2. Intraoperative Data of All Patients Internal stent group (n ¼ 31)

Type of biliary reconstruction Duct-to-duct anastomosis Roux-en-Y hepaticojejunostomy Operation time (min), mean  SD (range) Transfusion (pints), mean  SD (range) Red blood cells Platelets Fresh frozen plasma

30 (96.77%) 1 (3.23%) 885  241 (515e1,430) 22.71  22.93 (0e117) 3.58  9.50 (0e35) 10.13  13.78 (0e48)

No stent group (n ¼ 17)

16 (94.12%) 1 (5.88%) 750  139 (590e1,130) 23.41  14.21 (9e69) 17.82  15.77 (0e48) 24.29  15.87 (2e67)

P value

.5 .43 .31 .21 .08 .07

858

Table 3. Multivariate Logistic Regression Analysis for Biliary Complication Anastomotic stricture

Biliary obstruction

95% CI

Donor age (y) Donor sex (M/F) Recipient age (y) Recipient sex (M/F) Recipient body weight (kg) Cause of liver transplantation Alcoholic cirrhosis Hepatitis Berelated cirrhosis Hepatitis Cerelated cirrhosis Fulminant hepatitis Hepatocellular carcinoma MELD score Graft type (whole/partial) Graft type (right/left) Number of graft bile duct openings Size of graft bile duct (mm) Type of biliary reconstruction (DD/HJ) Operation time (min) Transfusion (pints) Red blood cells Platelets Fresh frozen plasma Use of internal stent

Bile leak

95% CI

Total biliary complications 95% CI

95% CI

P value

OR

Lower

Upper

P value

OR

Lower

Upper

P value

OR

Lower

Upper

P value

OR

Lower

Upper

.33 .71 .52 .83 .81

1.18 0.27 0.99 1.00 0.80

0.06 0.05 0.21 0.23 0.03

3.21 0.85 2.36 1.38 1.18

.75 .25 .41 .50 .47

1.20 0.23 0.95 1.13 0.42

0.02 0.04 0.09 0.29 0.02

2.26 1.24 1.89 1.81 0.96

.36 .45 .42 .62 .27

1.30 0.40 1.28 0.55 0.24

0.01 0.05 0.04 0.13 0.02

2.71 0.78 3.66 0.93 0.62

.55 .24 .55 .58 .59

1.50 1.12 1.15 0.70 0.71

0.01 0.05 0.09 0.02 0.13

2.02 1.50 2.05 1.08 1.09

.55 .52 .16 .66 .34 .53 .75 .82 .85 .54 .74 .21

0.59 0.84 0.41 0.68 0.71 1.15 0.48 0.85 0.97 0.89 0.45 1.25

0.08 0.07 0.03 0.09 0.06 0.01 0.02 0.08 0.05 0.12 0.03 0.01

0.97 1.22 0.97 1.06 1.09 3.03 0.86 1.23 1.08 1.27 0.83 3.93

.30 .64 .13 .68 .71 .64 .68 .73 .15 .37 .64 .77

0.27 0.57 0.12 0.61 0.76 1.57 0.61 0.66 0.98 1.23 0.57 1.16

0.01 0.05 0.02 0.07 0.25 0.05 0.08 0.01 0.04 0.09 0.07 0.21

0.78 1.14 1.25 1.19 1.37 3.14 1.19 1.25 1.28 3.13 1.14 3.28

.75 .85 .61 .16 .41 .45 .57 .25 .16 .41 .69 .76

0.68 0.77 0.55 0.14 0.37 1.14 1.51 0.23 0.95 0.37 0.62 1.19

0.01 0.02 0.03 0.09 0.06 0.01 0.08 0.01 0.05 0.26 0.11 0.02

1.06 1.15 0.93 0.97 0.75 2.78 1.89 0.61 0.97 2.61 1.00 2.97

.37 .59 .13 .40 .28 .54 .55 .19 .37 .12 .62 .55

0.45 0.71 1.19 0.48 0.34 1.65 0.66 0.23 0.94 0.14 0.74 1.26

0.01 0.12 0.03 0.09 0.06 0.15 0.08 0.15 0.05 0.26 0.03 0.12

0.83 1.09 1.57 0.86 0.72 3.03 1.04 1.09 0.83 2.61 1.12 3.14

.94 .85 .51 .04*

0.80 1.41 0.98 0.58

0.03 0.02 0.20 0.05

1.18 3.82 1.36 0.94

.15 .97 .46 .77

0.71 0.62 0.85 0.95

0.18 0.25 0.16 0.21

4.31 2.21 1.48 1.60

.41 .25 .57 .33

1.37 1.20 0.81 0.65

0.03 0.02 0.2 0.15

3.75 3.61 1.19 1.03

.85 .37 .62 .04*

1.02 1.15 1.74 0.62

0.09 0.06 0.12 0.09

3.40 3.84 4.21 0.98

JUNG, KIM, YU ET AL

Abbreviations: OR, odds ratio; CI, confidence interval; DD, duct-to-duct anastomosis; HJ, Roux-en-Y hepaticojejunostomy. *P < .05.

INTERNAL STENT FOR BILIARY ANASTOMOSIS

stricture developed were 1 day and 9 months, respectively. Bile leak was diagnosed with the use of computerized tomography and treated with the use of ERCP, and anastomotic stricture was diagnosed and treated with the use of ERCP. In the no stent group, there were 3 biliary complications: 2 anastomotic strictures and 1 biliary obstruction. The time intervals during which the 2 anastomotic strictures developed were 6 months and 20 months. The 2 anastomotic strictures were diagnosed and treated with the use of ERCP. Biliary obstruction occurred with common bile duct stone 9 months after surgery and was treated with the use of ERCP. The most frequent complication was anastomotic stricture in both groups. The rate of anastomotic stricture was 3.23% (n ¼ 1) in the internal stent group and 11.76% (n ¼ 2) in the no stent group. The rate of bile leak was 3.23% (n ¼ 1) in the internal stent group and 0% in the no stent group. The rate of biliary obstruction was 0% in the internal stent group and 5.88% (n ¼ 1) in the no stent group. We examined risk factors affecting each biliary complication with the use of multivariate logistic regression analysis. In multivariate analysis, use of internal stent was of benefit to prevent anastomotic stricture (odds ratio [OR], 0.58; 95% confidence interval [CI], 0.05e0.94; P ¼ .04) and total biliary complication (OR, 0.62; 95% CI, 0.09e0.98; P ¼ .04). But there were no significant factors affecting biliary obstruction and bile leak (Table 3). The cumulative 3-year patient survival rate was 93.5% in the internal stent group and 87.8% in the no stent group. This difference was not significant. The death rate directly related to biliary complication was 0%. The graft survival rate was similar in the 2 groups (93.5% in the internal stent group, 87.8% in the no stent group). There was no retransplantation in both groups. DISCUSSION

Biliary complications are a common source of morbidity after LT, leading to long-term and repeated therapies, including percutaneous, endoscopic, and surgical procedures [2,3]. Biliary reconstruction over a T-tube used to be the standard technique in most transplant centers. T-Tube drainage allows easy radiologic access to the biliary tree and monitoring of the quality of biliary flow. It may decrease the anastomotic stricture rate and lead to biliary decompression [4]. However, the incidence of biliary complications with a T-tube is high, ranging from 10% to 50% in large clinical series [5]. One-half of these biliary complications seem to be directly related to the presence of the T-tube [6]. Because of the disadvantages associated with the use of a T tube, many authors have advocated nonsplinted biliary duct reconstruction. But a prospective randomized trial conducted in Berlin [7] comparing side-to-side choledochocholedochostomy

859

with versus without T-tube noted significant differences in biliary complication incidence favoring the use of a T-tube (P ¼ .0005). Moreover, a recent prospective randomized trial by Lopez-Andujaret al [8] reported a significantly lower incidence of anastomotic stricture when a T-tube was used in deceased-donor LT, whereas the overall biliary complication rate was similar between T-tube group and nonsplinted group. We found that the overall rate of biliary complication in the no stent group was higher than in the internal stent group. According to earlier studies, biliary strictures and anastomotic leaks are the most common biliary complications. Other complications include sphincter of Oddi dysfunction, biliary obstruction (stones, sludge, or casts), mucocele, and hemobilia [9]. Biliary strictures after LT have been classified as anastomotic stricture and nonanastomotic stricture. These types of stricture differ in pathology, risk factors, and therapy. Nonanastomotic strictures are ischemic-type biliary lesions. In our study, the rate of biliary stricture in the stent group (3.23%) was significant lower than in the no stent group (11.76%). In the no stent group, the estimated hazard ratio was 2.12 (95% CI, 1.45e4.07; P < .05). The use of internal stent may helpful to protect against anastomotic strictures. Leaks after LT may also be divided into anastomotic leaks and T-tubeerelated leaks located at the insertion site either while the tube is in place or after its removal. In our study, 1 case of anastomotic leak was found in the internal stent group on postoperative day 1. Balderramo et al [3]. reported that biliary obstructions occur in w5% of cases, most caused by stones. Management of biliary obstructions in transplant patients does not differ from that in a nontransplant population, mainly an endoscopic approach by sphincterotomy and removal. In our study, biliary obstruction occurred only in the no stent group, at a rate of 5.88% (n ¼ 1), and the cause of obstruction was common bile duct stone. Another important point of discussion is the management of biliary complication. Although the biliary complication rate was greater in the no stent group, there was no increase in the number of patients needing operative procedures. All of biliary complications in the both groups were successfully treated with endoscopic and radiologic intervention. In conclusion, use of the internal stent may be helpful to decrease biliary complication rate and, if biliary complications occur with internal stent, most of the biliary complications can be treated successfully with endoscopic and radiologic intervention.

REFERENCES [1] Stratta RJ, Wood RP, Langnas AN, et al. Diagnosis and treatment of biliary tract complications after orthotopic liver transplantation. Surgery 1989;106:675e84. [2] Akamatsu N, Sugawara Y, Hashimoto D, et al. Biliary reconstruction, its complications and management of biliary complications after adult liver transplantation: a systematic review

860 of the incidence, risk factors and outcome. Transplantation 2011;24:379. [3] Balderramo D, Navasa M, Cardenas A, et al. Current management of biliary complications after liver transplantation: emphasis on endoscopic therapy. Gastroenterol Hepatol 2011;34:107. [4] Shaked A. Use of T-tube in liver transplantation. Liver Transplant Surg 1997;3(5 Suppl 1):22e3. [5] Vallera RA, Cotton PB, Clavien PA, et al. Biliary reconstruction for liver transplantation and management of biliary complications: overview and survey of current practices in the United States. Liver Transplant Surg 1995;1:143e52. [6] Rouch DA, Emond JC, Thistlethwaite JR Jr, et al. Choledochocholedochostomy without a T-tube or internal stent in

JUNG, KIM, YU ET AL transplantation of the liver. Surg Gynecol Obstet 1990;170: 239e44. [7] Weiss S, Schmidt SC, Ulrich F, et al. Biliary reconstruction using a side-to-side choledochocholedochostomy with or without T-tube in deceased donor liver transplantation. A prospective randomized trial. Ann Surg 2009;250:766. [8] Lopez-Andujar R, Montalvá E, Frangi A, et al. T-tube or not T-tube in deceased donor liver transplantation. Preliminary results of a prospective randomized trial. Liver Transplantation 2011;17 (Suppl 1):79A. [9] Gastaca M. Biliary complications after orthotopic liver transplantation: a review of incidence and risk factors. Transplant Proc 2012;44:1545e9.

Clinical outcome of internal stent for biliary anastomosis in liver transplantation.

This study analyzed the incidence and management of biliary complications after liver transplantation (LT) with or without internal stent...
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