Y-shaped endoscopic bilateral metal stent

Scandinavian Journal of Gastroenterology, 2011; 46: 326–332

ORIGINAL ARTICLE

Y-shaped endoscopic bilateral metal stent placement for malignant hilar biliary obstruction: prospective long-term study

Scand J Gastroenterol Downloaded from informahealthcare.com by A-Jou University on 06/11/15 For personal use only.

JAE CHUL HWANG, JIN HONG KIM, SUN GYO LIM, SOON SUN KIM, BYUNG MOO YOO & SUNG WON CHO Department of Gastroenterology, Ajou University School of Medicine, Suwon, Republic of Korea

Abstract Objective. Although still controversial, bilateral stenting may be the best option for palliative drainage of malignant hilar biliary obstruction. The aim of our study was to evaluate the technical and clinical efficacies of endoscopic bilateral metal stenting using a biliary Y-stent for the management of malignant hilar obstruction. Material and methods. This prospective, uncontrolled study included 30 consecutive patients with unresectable malignant hilar strictures in whom we intended to perform endoscopic bilateral stent-in-stent deployment using a biliary Y-stent. After deployment of the Y-stent across the hilar stricture, a conventional biliary metal stent was inserted in a Y-configuration in which it traversed the wider-mesh central portion of the Y-stent to enter the opposite hepatic lobe. Results. Bilateral metal stenting using a Y-stent was successful in 26 of 30 patients (86.7%), and successful drainage was achieved in all 26 patients (100%). Early complications occurred in 3 patients (cholangitis, 1; cholecystitis, 2) without procedure-related mortality. As late complications during the followup period (median, 176 days; range, 70–473 days), stent occlusion occurred in 10 of 26 patients (38.5%). Four patients were managed with the insertion of a plastic stent through the occluded metal stent, and the remaining patients were treated with percutaneous biliary drainage. The median survival and stent patency were 176 days and 140 days, respectively. Conclusions. Y-shaped endoscopic bilateral stenting using a Y-stent appears to be a feasible and effective method with high technical success and low stent-related complications for palliation of unresectable malignant hilar biliary obstruction.

Key Words: Bilateral drainage, endoscopic biliary drainage, malignant hilar biliary obstruction, self-expandable metal stent

Introduction The management of malignant hilar obstruction is viewed as a challenging clinical problem with a relatively poor prognosis. Although cholangiocarcinoma of the hilum accounts for the majority of patients with hilar strictures, other etiologies include gallbladder carcinoma, lymph node metastasis, and pancreatic carcinoma [1]. Surgery, involving hepatic resection if necessary, offers the only chance of cure, but most patients are not good candidates for curative resection [2]. Thus, a large number of patients are referred for palliative drainage. Although the necessity of bilateral drainage for hilar biliary strictures is controversial, an increased risk of

cholangitis has been described if only one side is drained when bile ducts of both hepatic lobes are contaminated [3–5]. Endoscopic bilateral stenting using conventional metal stents is considered technically difficult in patients with hilar biliary strictures because the second stent is not easily inserted once the first stent is deployed within the bile duct lumen. However, improvements in stents and devices for endoscopic intervention have led to increased use of endoscopic bilateral stenting. A biliary Y-stent with a wider-mesh central portion has been recently introduced to facilitate passage of the second metal stent during bilateral stenting. The aim of the present study was to evaluate the technical and clinical efficacy of endoscopic bilateral metal stent placement

Correspondence: Jin Hong Kim, MD, PhD, Department of Gastroenterology, Ajou University School of Medicine, San-5, Woncheon-dong, Yongtong-gu, 442-749 Suwon, Republic of Korea. Fax: +82 31 219 5999. E-mail: [email protected]

(Received 7 August 2010; accepted 22 October 2010) ISSN 0036-5521 print/ISSN 1502-7708 online 2011 Informa Healthcare DOI: 10.3109/00365521.2010.536253

Bilateral metal stenting for malignant hilar obstruction using a biliary Y-stent for the palliative drainage of malignant hilar strictures.

A

B

327

C

Methods


Patients A prospective, uncontrolled single center study was conducted to evaluate the efficacy of endoscopic drainage using bilateral metal stents in 30 patients (mean age, 68 years; range, 51–84 years; 20 males and 10 females) with unresectable malignant hilar obstruction between July 2002 and April 2008. The patients with malignant hilar obstruction of Bismuth type II or higher were included in this study [2]. All patients were considered to have unresectable tumors on the basis of tumor extent or general medical condition. Diagnosis was based on ultrasound (US), computed tomography (CT), magnetic resonance cholangiopancreatography, and endoscopic retrograde cholangiopancreatography (ERCP). Histologic and/or cytologic evidence of malignancy was established by percutaneous biopsy (US- or CTguided) or by endoscopic brushing cytology and forceps biopsy. Patients with no histologic evidence were diagnosed as having malignant disease on the basis of clinical outcome during follow-up. All patients in whom bilateral metal stenting was successful were followed up from stent insertion until death. Full and informed consent was obtained from all patients. The study was approved by the Ethical Committee of our Internal Review Board. Technique Prophylactic treatment with broad-spectrum antibiotics (third-generation cephalosporin) was initiated before the procedure and withdrawn 5 days later. All patients were intravenously sedated using midazolam with meperidine and/or propofol under appropriate cardiopulmonary monitoring. The endoscopes used for this procedure were Olympus JF260V or TJF240 (Olympus, Tokyo, Japan) with large working channels (3.7 and 4.2 mm, respectively). Endoscopic sphincterotomy was performed in all patients to facilitate stent placement. The biliary Y-stent was a self-expandable metal stent (SEMS, Niti-S Y-stent; Taewoong Medical, Seoul, Korea) in a cylindrical configuration with a 10-mm wider-mesh central portion and on either side of the wide mesh portion was mesh formed in the conventional mesh structure (Figure 1). The biliary Y-stent was produced with a single strand of nitinol wire, and its ends were formed to make a smooth, curved structure so as to not

Figure 1. Pictures of the stent used in this study. (A) Biliary Y-stent with central wide-open mesh; (B) Biliary Nitis-S stent with closed-cell-design; (C) Zilver stent with open-cell-design.

expose the sharp wire ends. The fully expanded stent was 10 mm in diameter and 6 or 7 cm in length, and the delivery system had a diameter of 8.5F. The second stent, a conventional SEMS (biliary Niti-S stent; Taewoong Medical, Seoul, South Korea) which had a 6–8 cm length and a fully expanded diameter of 10 mm, was introduced via the central mesh of the Y-stent. The stent had closed-cell design and the delivery system had a diameter of 8.5F (Figure 1). In cases in which insertion of the biliary Niti-S stent was not feasible, a Zilver stent (Cook Endoscopy, Winston-Salem, NC, USA) was used as the second stent. The stent had open-cell design and is preloaded in a 7F delivery system (Figure 1). The fully expanded diameter was 10 mm and the length of the stents was 6 or 8 cm. The stent placement technique was as follows: two stents were inserted in turn for the drainage of both liver lobes in a Y-shaped arrangement. After a guidewire was inserted across the hilar stricture, the Y-stent (i.e. the first stent) was endoscopically placed in the left or right hepatic duct, whichever was the more difficult side to access, using the standard method. The left stent is usually placed first as it is more difficult to access compared to the right stent. After dilation of the Y-stent with a biliary dilating balloon, a second guidewire was advanced from the

328

J. C. Hwang et al.

inside of the Y-stent out through the central widermesh portion into the contralateral intrahepatic duct and an attempt was made to insert the second stent along the guidewire (Figure 2). If the bilateral stent placement failed, percutaneous transhepatic biliary drainage (PTBD) was performed for biliary decompression of the undrained contralateral hepatic lobe.


Follow-up and definition of events The outcome of hepatic duct drainage was evaluated according to the following parameters: (1) technical success (successful stent insertion); (2) functional success (successful drainage); (3) early complications and procedure-related mortality; (4) late complications; (5) stent patency; and (6) survival. The intention-to-treat (ITT) and per protocol (PP) methods were used in this analysis. The ITT analysis was based on the original total cohort of subjects enrolled. The PP analysis was based on the subset of patients in whom bilateral metal stenting was successful. We evaluated the rate of successful stent insertion and early complications by ITT analysis. The rate of successful drainage, late complications, stent patency, and survival were evaluated by PP analysis. Successful stent insertion was defined as passage of the stent across the stricture, along with flow of contrast and/or bile through the stent. Successful drainage was defined as a decrease in bilirubin to