- Email: [email protected]
A newly designed plastic stent for EUS-guided hepaticogastrostomy: a prospective preliminary feasibility study (with videos)
NEW METHODS: Clinical Endoscopy
A newly designed plastic stent for EUS-guided hepaticogastrostomy: a prospective preliminary feasibility study (with videos) Junko Umeda, MD, Takao Itoi, MD, FASGE, Takayoshi Tsuchiya, MD, Atsushi Sofuni, MD, Fumihide Itokawa, MD, Kentaro Ishii, MD, Shujiro Tsuji, MD, Nobuhito Ikeuchi, MD, Kentaro Kamada, MD, Reina Tanaka, MD, Ryosuke Tonozuka, MD, Mitsuyoshi Honjo, MD, Shuntaro Mukai, MD, Mitsuru Fujita, MD, Fuminori Moriyasu, MD Tokyo, Japan
Background: There are currently no dedicated plastic stents for EUS-guided hepaticogastrostomy (EUS-HGS). Objective: We prospectively evaluated the feasibility and the technical and functional success rates of our newly designed plastic stent for EUS-HGS. Design: Prospective preliminary feasibility study. Setting: A tertiary-care referral center. Patients: Twenty-three consecutive patients were treated. The reasons for requiring EUS-HGS were periampullary tumor invasion (n Z 9), altered anatomy (n Z 7), failed duodenal intubation (n Z 3), and previous ERCP failure (n Z 4). Interventions: An 8F single-pigtail plastic stent with 4 flanges was placed for EUS-HGS. Main Outcome Measurements: Technical success, clinical success, and adverse events according to the American Society for Gastrointestinal Endoscopy lexicon. Results: All stents were successfully deployed without procedural adverse events (100% technical success rate). Bleeding from the punctured gastric wall occurred in 1 patient 3 days postoperatively. We exchanged the plastic stent for a fully covered self-expandable metal stent. A mild adverse event of self-limited abdominal pain occurred in 3 patients. Treatment success was achieved in all patients. The occlusion rate was 13.7% (3/22) during the median follow-up period (5.0 months, range 0.5-12.5 months). The median duration of stent patency was 4.0 months (range 0.5-9.0 months). There was no stent migration or dislocation during the follow-up period. Limitations: Small number of patients and lack of a control group. Conclusions: This newly designed single-pigtail plastic stent dedicated for EUS-HGS was technically feasible and can possibly be used for highly selected patients with advanced malignancy or benign stricture. (Trial Registration: http://www.umin.ac.jp/english/: UMIN000012993.)
EUS-guided hepaticogastrostomy (EUS-HGS) for the creation of a fistula between the stomach and the left intrahepatic bile duct is an EUS-guided biliary drainage technique.1,2 Although EUS-HGS has a high technical
success rate of 87%,3-9 its procedure-related adverse event rate of 27% was reportedly higher than the rates of other EUS-guided biliary interventions (eg, EUSguided choledochoduodenostomy, 19%; rendezvous,
Abbreviations: CMS, covered metal stent; EUS-HGS, EUS-guided hepaticogastrostomy; GJ, gastrojejunostomy; TGþR-Y, total gastrectomy þ Rouxen-Y gastric bypass.
Received November 2, 2014. Accepted February 18, 2015.
DISCLOSURE: All authors disclosed no financial relationships relevant to this article.
Current affiliation: Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan. Reprint requests: Takao Itoi, MD, PhD, FASGE, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku, Tokyo 160-0023, Japan.
Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2015.02.041
390 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
www.giejournal.org
Umeda et al
Newly designed plastic stent for EUS-guided hepaticogastrostomy
11%; and antegrade stenting, 5%).10 Furthermore, 1 fatal case of stent migration on the gastric side in the abdominal cavity after EUS-HGS has been reported.11 We developed a new single-pigtail plastic stent designed for EUS-HGS and prospectively evaluated its feasibility as well as its technical and functional success rates.
PATIENTS AND METHODS Patients Twenty-three patients with biliary obstruction caused by benign or malignant biliary strictures or common bile duct stones underwent EUS-HGS at Tokyo Medical University Hospital between December 2013 and September 2014.
EUS-hepaticogastrostomy The indications for EUS-HGS at our institution were previously described as follows1,2 (1) impossible biliary cannulation; (2) inaccessible papilla due to surgically altered anatomy or gastric outlet obstruction; (3) contraindicated percutaneous transhepatic biliary drainage (eg, large amount of ascites and self-removal of the drain due to severe dementia). EUS-HGS was performed by skilled endosonographers (T.I. and T.T.) with patients under conscious sedation by intravenous medication (Fig. 1). All patients were given intravenous antibiotics prophylactically. Our standard EUS-HGS stenting procedure is as follows.
Figure 1. Drawing of a EUS-hepaticogastrostomy by using the newly developed plastic stent. The new plastic stent was placed in the left intrahepatic bile duct.
Japan (PK6-8F20P-4X12; Gadelius Medical Co, Ltd, Tokyo, Japan) (Fig. 2) was placed in the bile duct above the stricture.
Common bile duct stone cases
Therapeutic echoendoscopes were used with carbon dioxide insufflation. Standard 19-gauge and 22-gauge fine needles were used to puncture the dilated left intrahepatic bile duct. After contrast medium injection, an insulated guidewire (0.025-inch VisiGlide; Olympus Medical Systems, Tokyo, Japan, for the 19-gauge needle or 0.021-inch Metro; Cook Medical, Bloomington, Ind, for 22-gauge needle) was advanced antegrade into the bile duct. Dilation of the needle tract and anastomotic site was performed by using a standard or tapered catheter, a cautery dilator (6.5F Cyst-Gastro set; Endoflex, Voerde, Germany), an 8F dilation catheter (Soehendra dilator; Cook Medical), and/or a 4-mm-diameter dilating balloon (Hurricane; Boston Scientific, Natick, Mass). Finally, a newly designed 8F plastic stent approved for use in
The guidewire was passed across the major papilla for the subsequent procedure. After tract dilation, endoscopic papillary balloon dilation (12-15 mm in diameter) was performed in an antegrade fashion. Common bile duct stones were extracted in an antegrade fashion by using a balloon retrieval catheter. Finally, an 8F plastic stent was placed in the extrahepatic bile duct above the papilla. The primary endpoint of this study was technical success and the secondary endpoint was adverse events. Technical success was defined as stent placement in the bile duct. Treatment success was defined as complete resolution of obstructive jaundice, stone removal, resolution of strictures, and/or resolution of clinical symptoms. Adverse events possibly related to the procedure were described according to the ASGE lexicon.12 All data were collected and taken care by only fixed endoscopists ( J.U., chief; K.I., S.T., N.I., K.K., R.T., R.T., and M.H., cooperators). For follow-up, in patients with bile duct stones, we scheduled stent removal in 1 or 2 months after the initial EUS-HGS. In patients with malignant obstruction, we did not schedule a regular stent exchange procedure but carried out the following procedure as needed. The guidewire (0.025-inch VisiGlide) was advanced in the common bile duct alongside the plastic stent (parallel cannulation
www.giejournal.org
Volume 82, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 391
Stent The plastic stent, which is a push-type stent and is usually not possible to retract, has a total length of 20 cm, an effective length of 15 cm, and 4 flanges (2 at the distal end and 2 at the proximal end). The proximal end has a pigtail structure and the distal end is tapered (Fig. 2).
Biliary stricture cases
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Umeda et al
Figure 2. The new plastic stent designed for EUS- hepaticogastrostomy stenting. Tapered tip and 4-fold–flanged single-pigtail bile duct stent (total length: 20 cm; effective length: 15 cm; flanges: 4 with apertures, side holes, total of 12 holes, distal straight site, 4 holes and pigtail site, 8 holes [Gadelius Medical Co, Ltd, Tokyo, Japan]).
Figure 3. Actual case presentation of EUS-hepaticogastrostomy stenting. The bile duct (segment 3) puncture was performed with a 19-gauge needle (A). A 0.025-inch guidewire was introduced through the EUS needle and advanced in an antegrade fashion (B). An 8F new plastic stent was placed in the bile duct. The site of the distal tip of the stent was the common bile duct (C). Endoscopic imaging of the proximal pigtail stent end (D).
technique) from the punctured gastric site by using a therapeutic duodenoscope and a tapered catheter. Then, the stent was removed by using snare forceps and rat-tooth grasping forceps, leaving the guidewire in place. Subsequently, a new stent was placed. CT was performed when stent occlusion and migration were suspected during the follow-up period. All patients provided written informed consent before the procedure. The study was approved by the institutional
review board of our hospital (no. 2503). This trial was registered at UMIN (UMIN000012993).
392 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
www.giejournal.org
RESULTS Twenty-three patients (median age, 77 years; 15 men) underwent EUS-HGS stenting (Fig. 3). Patient characteristics are summarized in Table 1. The reasons for requiring EUS-
Umeda et al
Newly designed plastic stent for EUS-guided hepaticogastrostomy
TABLE 1. Patient characteristics
Age, y/sex
Primary diseases
Reason for EUS-HGS
Altered anatomy
Stricture site
Previous ERCP attempt
Bilirubin level, mg/dL
1
73/F
CBD stone
Altered anatomy
TGþR-Y
d
Yes
0.47
2
65/M
Ampullary cancer
Periampullary tumor invasion
d
Bi
No
3.01
3
78/M
CBD stone
Failed duodenal intubation
Post-DP
d
Yes
0.5
4
58/M
Postoperative stricture
Previous ERCP failure
Billroth I, Lap-c
CHD
Yes
3.93
5
83/M
Pancreatic cancer
Failed duodenal intubation
Post DP
Bi
Yes
6.71
6
83/F
Pancreatic cancer
Altered anatomy
TGþR-Y
Bi
Yes
7.55
7
63/M
Pancreatic cancer
Altered anatomy
Choledochojejunostomy
Anastomosis
No
0.72
8
89/F
Pancreatic cancer
Periampullary tumor invasion
d
Bi
Yes
2.5
9
61/M
Postoperative stricture
Altered anatomy
Post Lap-PD
Anastomosis
No
0.79
10
78/F
Metastatic lymph nodes
Failed duodenal intubation
Post GJ þ Braun
Bi
Yes
8.85
11
68/M
Bile duct cancer
Previous ERCP failure
d
Bs
Yes
2.06
12
46/M
Pancreatic cancer
Periampullary tumor invasion
GJ
Bi
Yes
19.76
13
58/M
Pancreatic cancer
Periampullary tumor invasion
GJ
Bi
No
0.76
14
81/M
Pancreatic cancer
Periampullary tumor invasion
GJ þ cholecystojejunostomy
Bi
No
0.99
15
79/F
Pancreatic cancer
Previous ERCP failure
d
Bi
Yes
9.48
16
53/F
Pancreatic cancer
Periampullary tumor invasion
d
Bi
Yes
0.63
17
90/F
CBD stone
Altered anatomy
Billroth II
Bi
Yes
2.11
18
76/M
Pancreatic cancer
Periampullary tumor invasion
d
Bi
Yes
17.21
19
78/M
Bile duct cancer
Previous ERCP failure
d
Bi
Yes
17.53
20
81/M
CBD stone
Altered anatomy
TGþR-Y
d
Yes
1.78
Case
21
66/M
CBD stone
Altered anatomy
TG þ jejunal interposition
d
Yes
4.42
22
80/M
Ampullary cancer
Periampullary tumor invasion
d
Bi
No
1.35
23
82/M
Duodenal cancer
Periampullary tumor invasion
d
Bi
Yes
3.9
EUS-HSG, EUS-guided hepaticogastrostomy; F, female; CBD, common bile duct; TGþR-Y, total gastrectomy þ Roux-en-Y gastric bypass; M, male; Bi, inferior site of extrahepatic bile duct; DP, distal pancreatectomy; Lap-c, laparoscopic-cholecystedomy; CHD, common hepatic duct; Lap-PD, laparoscopic pancreatoduodenectomy; GJ þ Braun, gastrojejunostomy with Braun anastomosis; Bs, superior site of extrahepatic bile duct.
HGS were periampullary tumor invasion (n Z 9), altered anatomy (n Z 7), failed duodenal intubation (n Z 3), and prior ERCP failure (n Z 4). The outcomes of EUS-HGS stenting are shown in Table 2. The mean intrahepatic bile duct diameter measured by EUS at the time of puncture was 5.5 mm (range 2.5-10 mm). A 19-gauge needle (Video 1, available online at www.giejournal.org) and a 22-gauge needle (Video 2, available online at www.giejournal.org) were used in 14 patients and 9 patients, respectively. Bleeding
(not pulsating but oozing) from the punctured gastric wall occurred in 1 patient 3 days postoperatively with a decrease in the hemoglobin level (from 11.9 mg/dL to 10.5 mg/dL) and without the need for a blood transfusion. We exchanged the plastic stent for a fully covered selfexpandable metal stent (8 mm in diameter; WallFlex, Boston Scientific Japan, Tokyo, Japan). In this case, a 4-mm dilating balloon after tract dilation by using a cautery dilator was used. Hemostasis was achieved by metal stent placement,
www.giejournal.org
Volume 82, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 393
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Umeda et al
TABLE 2. Outcome of EUS-guided hepaticogastrostomy stenting Acute adverse events* (severity grade*)
Procedure Punctured BD Needle, Tract Technical duration, Case diameter, mm gauge dilation, mm success min
Stent Scheduled stent occlusion exchange or (time to removal (time to Stent FU Treatment occlusion), exchange or patency, duration, success mo removal), mo moy moz
1
10
19
CDþDB
Yes
30
No
Yes
No
Removal, 2
2
11
2
8
19
DB
Yes
10
Abdominal pain (mild)
Yes
No
Exchange, 4
4
8
3
5
22
DC
Yes
35
No
Yes
No
No
1.5x
1.5
4
5
19
CDþDB
Yes
15
Yes
N/A
N/A
N/A
10
5
5
22
DC
Yes
25
No
Yes
Yes (2)
N/A
2
5
6
6
22
CDþDB
Yes
16
No
Yes
No
No
4
4
7
6
22
CDþDB
Yes
20
No
Yes
No
No
4.5
4.5
8
10
19
DC
Yes
30
No
Yes
No
No
8
8
9
4
19
DC
Yes
20
No
Yes
No
Exchange (2.5)
2.5
12.5
Bleeding (moderate)
10
6
19
DC
Yes
16
No
Yes
No
No
0.5x
0.5
11
4.5
22
CD
Yes
20
No
Yes
No
No
7.5
7.5
12
2.5
22
DB
Yes
38
No
Yes
No
No
9
9
13
9
19
CDþDC
Yes
10
Abdominal pain (mild)
Yes
No
No
2.5x
2.5
14
4.5
22
CD
Yes
33
No
Yes
No
No
4
4
15
9
19
DC
Yes
25
No
Yes
Yes (3)
N/A
3
6.5
16
9
19
CDþDB
Yes
9
Abdominal pain (mild)
Yes
No
No
4
4
17
5
19
DC
Yes
23
No
Yes
No
No
4
4
18
9
19
CD
Yes
19
No
Yes
No
No
4
4
19
8
22
CD
Yes
24
No
Yes
No
Removal (1k)
1
5
20
2.5
22
DC
Yes
26
No
Yes
No
No
4.5
4.5
21
5
19
DC
Yes
63
No
Yes
No
Removal (2)
2
6
22
5
19
CD
Yes
10
No
Yes
No
No
4.5
4.5
23
6
19
CD
Yes
22
No
Yes
Yes (0.8)
N/A
0.8
7
BD, Bile duct; FU, follow-up; CDþDB, cautery dilator þ dilating balloon catheter; DC, dilation catheter; N/A, not applicable. *According to American Society for Gastrointestinal Endoscopy lexicon. yStent patency: 4 months (median), range 0.5-9. zFollow-up duration: 5 months (median), range 0.5-12.5. xPatent until death. kDuration until surgery.
and rebleeding did not occur. A mild adverse event of selflimited abdominal pain occurred in 3 patients. The technical success rate was 100%, and the mean procedure time was 22.8 minutes. Treatment success was achieved in all patients. Total bilirubin was normalized in all patients with obstructive jaundice (n Z 14, total bilirubin O2.0 mg/dL). The stent occlusion rate was 13.7% (3/22) during the follow-up period (median 5.0 months, range 0.5-12.5 months). The median duration of stent patency was 4.0 months (range 0.5-9.0 months). Scheduled stent exchange was performed in 2 patients and stent removal in 3 patients. In 3 patients, stent
obstruction occurred within 2 months and required stent exchange (Fig. 4; Videos 3 and 4, available online at www. giejournal.org); however, there was no stent migration or dislocation during the follow-up period.
394 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
www.giejournal.org
DISCUSSION EUS-HGS was first reported by Giovanini et al3 in 2003. Since then, it has become an alternative to percutaneous transhepatic biliary drainage or surgery after failed ERCP
Umeda et al
over the past decade (Supplementary Tables 1 and 2). To date, existing ERCP plastic or metal biliary stents, particularly straight-tip plastic stents at the early stage, have been used for EUS-HGS stenting (Supplementary Table 1). However, the current plastic stent was not ideal for EUS-HGS because its tip ( bile duct side) was not tapered. This reduced the straightening stability of the stent. The shape of the proximal end of the stent (gastric side) was straight with tiny flanges. The stent had the possibility of migrating into the abdominal cavity. Thus, we designed a new plastic stent dedicated for EUSHGS with these advantages: (1) the tapered and straight distal tip can be easily advanced in the liver and bile duct via the needle tract; (2) the 4 flanges and pigtail anchor of the stent can prevent proximal and distal stent migration, particularly on the gastric side; (3) a 15-cm effective stent length can be used for all patients regardless of their surgically altered anatomy; (4) relatively large apertures below the flanges and the 4 small holes in the distal end of the stent improve ductal drainage if the bile is turbid or concentrated like pus; (5) the absence of a hole in the middle part of the stent can prevent bile leakage into the peritoneal cavity; (6) a diameter of 8F can prevent left intrahepatic bile duct occlusion. In fact, our results showed that the stent could be easily placed in all cases (100%). Obstructive jaundice improved in all patients. In this study, we clarified the feasibility and effectiveness of this newly developed plastic stent for EUS-HGS. Bories et al9 reported that a covered metal stent (CMS) may be more preferable than a plastic stent. Theoretically, a CMS has the following potential advantages: (1) it affords better drainage owing to a larger bore stent than a plastic stent; (2) it prevents bile leakage and bile peritonitis13; and (3) it prevents bleeding from the tract due to a self-expandable stent. However, current CMSs may also have several disadvantages as follows: (1) they are more expensive than plastic stents, (2) popular CMSs worldwide are all braided-type stents, which show a high shortening rate of more than 40% and have a risk of fatal adverse events such as unexpected stent migration,11 although some CMSs do not foreshorten; (3) stent-related occlusion of the left intrahepatic bile ducts is possible; (4) overdilation of the narrow bile duct is possible. Of these disadvantages, difficulty of stent placement, particularly stent deployment by using a braided-type CMS is always problematic during EUSHGS. However, it has been reported in the literature that there is no obvious difference in the EUS-HGS outcome between a plastic stent and a metal stent (Table 3). Thus, a commercial dedicated CMS for EUSHGS is anticipated in the near future. Based on the characteristics of plastic stents and CMSs, we believe that stent selection depends on the patient’s condition (eg, benign or malignant), prognosis, and bile duct diameter. This may be similar to the strategy of transwww.giejournal.org
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Figure 4. Actual case presentation of stent exchange. The 0.025-inch guidewire was advanced in the common bile duct alongside the plastic stent (parallel cannulation technique) from the punctured gastric site using a therapeutic duodenoscope and a tampered catheter (A, endoscopic image, B, fluoroscopic image). Then, the stent was removed using a snare forceps, leaving the guidewire in place (C).
papillary stenting during ERCP. The newly designed plastic stent can therefore potentially contribute to a more reliable EUS-HGS procedure in selected patients. In this study, adverse events were observed in 17.4% (4/23) patients, which is comparable to those of previous single-center reports.10 The single moderate and 3 mild adverse events required no additional interventions except for the 1 case of bleeding. For the case of bleeding, a 4-mm dilating balloon was used after tract dilation by using a cautery dilator. Thereafter, only an 8F dilation catheter was used if needed after tract dilation with a cautery dilator. Further postprocedural bleeding was not observed. Caution was always taken to avoid overdilation of the tract beyond the stent diameter so as not to cause bile leakage. As a limitation, this preliminary study was performed at a single center with a small number of patients and without a control group. In conclusion, we designed a new single-pigtail plastic stent dedicated for EUS-HGS and confirmed its technical feasibility and clinical effectiveness. This plastic stent can possibly be used for highly selected patients with advanced malignancy or benign stricture. Additional long-term studies involving a sufficient number of patients are warranted. Volume 82, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 395
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Umeda et al
TABLE 3. Summary of medical literature of EUS-HGS when using plastic stents and metal stents* Stent
No.
Technical success rate, %
Clinical success rate, %
Adverse event rate, %
Mortality rate, %
Plastic stent
26
100 (26/26)
94.7 (18/19)
15.4 (4/26)
0.038 (1y/26)
Metal stent
147
95.2 (140/147)
91.6 (98/107)
16.3 (24/147)
0.007 (1z/134)
Current plastic stent
23
100 (23/23)
100 (23/23)
17.4 (4/23)
0
*Details are given described in Supplementary Tables 1 and 2. yOne patient who had septic shock before the first procedure died 4 days after procedure. zDue to stent migration.
ACKNOWLEDGMENTS The authors thank Dr Edward Barroga, Associate Professor and Senior Medical Editor, Tokyo Medical University, for editing the manuscript.
REFERENCES 1. Itoi T, Sofuni A, Itokawa F, et al. Endoscopic ultrasonography-guided biliary drainage. J Hepatobiliary Pancreat Sci 2010;17:611-6. 2. Itoi T, Tsuyuguchi T, Takada T, et al. TG 13 indications and techniques for biliary drainage in acute cholangitis (with videos). J Hepatobiliary Pancreat Sci 2013;20:71-80. 3. Giovanini M, Dotti M, Boris E, et al. Hepaticogastrostomy by echoendoscopy as a palliative treatment in a patient with metastatic biliary obstruction. Endoscopy 2003;35:1076-8. 4. Will U, Thieme A, Fueldner F, et al. Treatment of biliary obstruction in selected patients by endoscopic ultrasonography (EUS)-guided transluminal biliary drainage. Endoscopy 2007;39:292-5. 5. Burmester E, Niehaus J, Leineweber T, et al. EUS-cholangio-drainage of the bile duct: report of 4 cases. Gastrointest Endosc 2003;57:246-51.
396 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
6. Kahaleh M, Hernandez AJ, Tokar J, et al. Interventional EUS-guided cholangiography: evaluation of a technique in evolution. Gastrointest Endosc 2006;64:52-9. 7. Park DH, Koo JE, Oh J, et al. Endoscopic ultrasound-guided choledochoduodenostomy in patients with failed endoscopic retrograde cholangiopancreatography. World J Gastroenterol 2008;14: 6078-82. 8. Artifon EL, Chaves DM, Ishioka S, et al. Echoguided hepaticogastrostomy: a case report. Clinics 2007;62:799-802. 9. Bories E, Pesenti C, Caillol F, et al. Transgastric endoscopic ultrasonography-guided biliary drainage: results of pilot study. Endoscopy 2007;39:287-91. 10. Iwashita T, Doi S, Yasuda I. Endoscopic ultrasound-guided biliary drainage: a review. Clin J Gastroenterol 2014;7:94-102. 11. Martins FP, Rossini LG, Ferrari AP. Migration of a covered metallic stent following endoscopic ultrasound-guided hepaticogastrostomy: fatal complication. Endoscopy 2010;42(Suppl 2):E126-7. 12. Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:746-54. 13. Khashab MA, Valeshabad AK, Modayil R, et al. EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos). Gastrointest Endosc 2013;78:734-41.
www.giejournal.org
Umeda et al
Newly designed plastic stent for EUS-guided hepaticogastrostomy
SUPPLEMENTARY TABLE 1. Summary of medical literature of EUS-HGS when using plastic stents
Ref. Burmester1 2
No.
Puncture
Dilation method
Technical success rate, %
Clinical success rate, %
Adverse event rate, %
Mortality rate, %
1
FT
None
100
100
0
0
Giovanini
1
19G
NK
100
N/A
0
0
Kahaleh3
2
19G, 22G
N/A
100
100
0
0
Bories4
7
19G, 22G
Cystotome
100
100
5
19G
DC, DB
100
80
Horaguchi5 6
29 (2/7) (1 stent occlusion, 1 ileus) 0
0 0
Iwamuro
2
NK
DC
100
100
50 (1/2) (1 bile leak)
0
Ramirez-Luna7
2
19G
NK, DC
100
100
50 (1/2) (1 stent migration)
100% (1*/2)
Park8
6
19G
NK, DC
Total
26
100
NA
0
0
100% (26/26)
94.7% (18/19)
15.4% (4/26)
0.038% (1/26)
HGS, Hepaticogastrostomy; FT, fistulotomy; 19G/22G, 19-gauge/22-gauge FNA needle; NK, needle-knife; N/A, not applicable; DC, dilating catheter; DB, dilating balloon. *Patient who had septic shock before the first procedure died 4 days after procedure. 1.Gastrointest Endosc 2003;57:246-51. 2.Endoscopy 2003;35:1076-8. 3.Gastrointest Endosc 2006;64:52-9. 4.Endoscopy 2007;39:287-91. 5.Dig Endosc 2009;21:239-44. 6.Dig Endosc 2010;22:236-40. 7.Endoscopy 2011;43:826-30. 8.Gastrointest Endosc 2011;74:1276-84.
www.giejournal.org
Volume 82, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 396.e1
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Umeda et al
SUPPLEMENTARY TABLE 2. Summary of medical literature of EUS-HGS when using metal stents
No.
Access method
Dilation method
Stent
Technical success rate (%)
Clinical success rate, %
Adverse event rate, %
Mortality rate, %
1
19G
None
CMS
100
100
0 (0/1)
0
Will
4
19G
DC, DB
CMS
100
75
50 (2/4) (1 abdominal pain, 1 cholangitis)
0
Bories3
3
19G, 22G
Cystotome
CMS
100
100
67 (2/3) (2 migration)
0
Park4
8
19G
DC, NK
FCMS
100
100
0 (0/8)
0
Martins5
1
19G
NK
PCMS
100
N/A
100 (1/1) (1 migration)
100 (1/1)
Ref. Arifon1 2
Park6
5
19G
DC, NK
FCMS
100
100
0 (0/5)
0
Park7
25
19G
DC, NK
FCMS
100
N/A
24 (6/25) (N/A)
0
Fabbri8
1
19G
NK, DB
PCMS
0
d
0 (0/1)
d
Kim9
4
19G
DC, NK
FCMS
75
67
25 (1/4) (1 migration)
0
Tonozuka
3
19G
DC, DB
FCMS
100
N/A
0 (0/3)
0
Bapaye11
5
19G
CMS
60
N/A
33 (1/3) (1 peritonitis)
N/A
Ogura12
20
19G
SC
FCMS, PCMS
100
100
10 (2/20) (1 migration, 1 peritonitis)
0
Paik13
28
19G
SC, DB, NK
FCMS
96
89
0 (0/27)
0
Song14
10
19G
DC, NK
PCMS
100
100
Hamada15
4
19G
SC, DB, cystotome
CMS
75*
N/A
25 (1/4) (bleeding)
N/A
Artifon16
25
19G
DC, NK
PCMS
96
91
20 (5/25) (bacteremia 1, biloma 2, bleeding 3)
0
Total
147
95.2% (140/147)
91.6% (98/107)
16.3% (24/147)
0.007% (1/134)
10
DC, DB, cystotome, NK
30 (3/10) (1 bleeding, 2 pneumoperitoneum)
0
HGS, Hepaticogastrostomy; 19G/22G, 19-gauge/22-gauge fine-needle aspiration needle; CMS, covered metal stent; DC, dilating catheter; DB, dilating balloon; NK, needle-knife; FCMS, fully covered metal stent; N/A, not applicable; PCMS, partially covered metal stent; SC, standard catheter. *One case was a misplaced metal stent, but was subsequently managed by placing another metal stent in a tandem fashion. 1.Clinics (Sao Paulo) 2007;62:799-802. 2.Endoscopy 2007;39:292-5. 3.Endoscopy 2007;39:287-91. 4.Am J Gastroenterol 2009;104:2168-74. 5.Endoscopy 2010;42(Suppl 2):E126-7. 6.Gastrointest Endosc 2010;71:413-9. 7.Gastrointest Endosc 2011;74:1276-84. 8.Endoscopy 2011;43:438-41. 9.World J Gastroenterol 2012;18:2526-32. 10.Dig Endosc 2013;25(Suppl 2):100-8. 11.United Eur Gastroenterol J 2013;1:285-93. 12.J Gastroenterol Hepatol 2014;29:1815-21. 13.World J Gastroenterol 2014;20:5051-9. 14.Gastrointest Endosc 2014;80:707-11. 15.Dig Dis Sci 2014;59:1931-8. 16.Gastrointest Endosc 2014 Dec 12.
396.e2 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
www.giejournal.org
A newly designed plastic stent for EUS-guided hepaticogastrostomy: a prospective preliminary feasibility study (with videos) Junko Umeda, MD, Takao Itoi, MD, FASGE, Takayoshi Tsuchiya, MD, Atsushi Sofuni, MD, Fumihide Itokawa, MD, Kentaro Ishii, MD, Shujiro Tsuji, MD, Nobuhito Ikeuchi, MD, Kentaro Kamada, MD, Reina Tanaka, MD, Ryosuke Tonozuka, MD, Mitsuyoshi Honjo, MD, Shuntaro Mukai, MD, Mitsuru Fujita, MD, Fuminori Moriyasu, MD Tokyo, Japan
Background: There are currently no dedicated plastic stents for EUS-guided hepaticogastrostomy (EUS-HGS). Objective: We prospectively evaluated the feasibility and the technical and functional success rates of our newly designed plastic stent for EUS-HGS. Design: Prospective preliminary feasibility study. Setting: A tertiary-care referral center. Patients: Twenty-three consecutive patients were treated. The reasons for requiring EUS-HGS were periampullary tumor invasion (n Z 9), altered anatomy (n Z 7), failed duodenal intubation (n Z 3), and previous ERCP failure (n Z 4). Interventions: An 8F single-pigtail plastic stent with 4 flanges was placed for EUS-HGS. Main Outcome Measurements: Technical success, clinical success, and adverse events according to the American Society for Gastrointestinal Endoscopy lexicon. Results: All stents were successfully deployed without procedural adverse events (100% technical success rate). Bleeding from the punctured gastric wall occurred in 1 patient 3 days postoperatively. We exchanged the plastic stent for a fully covered self-expandable metal stent. A mild adverse event of self-limited abdominal pain occurred in 3 patients. Treatment success was achieved in all patients. The occlusion rate was 13.7% (3/22) during the median follow-up period (5.0 months, range 0.5-12.5 months). The median duration of stent patency was 4.0 months (range 0.5-9.0 months). There was no stent migration or dislocation during the follow-up period. Limitations: Small number of patients and lack of a control group. Conclusions: This newly designed single-pigtail plastic stent dedicated for EUS-HGS was technically feasible and can possibly be used for highly selected patients with advanced malignancy or benign stricture. (Trial Registration: http://www.umin.ac.jp/english/: UMIN000012993.)
EUS-guided hepaticogastrostomy (EUS-HGS) for the creation of a fistula between the stomach and the left intrahepatic bile duct is an EUS-guided biliary drainage technique.1,2 Although EUS-HGS has a high technical
success rate of 87%,3-9 its procedure-related adverse event rate of 27% was reportedly higher than the rates of other EUS-guided biliary interventions (eg, EUSguided choledochoduodenostomy, 19%; rendezvous,
Abbreviations: CMS, covered metal stent; EUS-HGS, EUS-guided hepaticogastrostomy; GJ, gastrojejunostomy; TGþR-Y, total gastrectomy þ Rouxen-Y gastric bypass.
Received November 2, 2014. Accepted February 18, 2015.
DISCLOSURE: All authors disclosed no financial relationships relevant to this article.
Current affiliation: Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan. Reprint requests: Takao Itoi, MD, PhD, FASGE, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku, Tokyo 160-0023, Japan.
Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2015.02.041
390 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
www.giejournal.org
Umeda et al
Newly designed plastic stent for EUS-guided hepaticogastrostomy
11%; and antegrade stenting, 5%).10 Furthermore, 1 fatal case of stent migration on the gastric side in the abdominal cavity after EUS-HGS has been reported.11 We developed a new single-pigtail plastic stent designed for EUS-HGS and prospectively evaluated its feasibility as well as its technical and functional success rates.
PATIENTS AND METHODS Patients Twenty-three patients with biliary obstruction caused by benign or malignant biliary strictures or common bile duct stones underwent EUS-HGS at Tokyo Medical University Hospital between December 2013 and September 2014.
EUS-hepaticogastrostomy The indications for EUS-HGS at our institution were previously described as follows1,2 (1) impossible biliary cannulation; (2) inaccessible papilla due to surgically altered anatomy or gastric outlet obstruction; (3) contraindicated percutaneous transhepatic biliary drainage (eg, large amount of ascites and self-removal of the drain due to severe dementia). EUS-HGS was performed by skilled endosonographers (T.I. and T.T.) with patients under conscious sedation by intravenous medication (Fig. 1). All patients were given intravenous antibiotics prophylactically. Our standard EUS-HGS stenting procedure is as follows.
Figure 1. Drawing of a EUS-hepaticogastrostomy by using the newly developed plastic stent. The new plastic stent was placed in the left intrahepatic bile duct.
Japan (PK6-8F20P-4X12; Gadelius Medical Co, Ltd, Tokyo, Japan) (Fig. 2) was placed in the bile duct above the stricture.
Common bile duct stone cases
Therapeutic echoendoscopes were used with carbon dioxide insufflation. Standard 19-gauge and 22-gauge fine needles were used to puncture the dilated left intrahepatic bile duct. After contrast medium injection, an insulated guidewire (0.025-inch VisiGlide; Olympus Medical Systems, Tokyo, Japan, for the 19-gauge needle or 0.021-inch Metro; Cook Medical, Bloomington, Ind, for 22-gauge needle) was advanced antegrade into the bile duct. Dilation of the needle tract and anastomotic site was performed by using a standard or tapered catheter, a cautery dilator (6.5F Cyst-Gastro set; Endoflex, Voerde, Germany), an 8F dilation catheter (Soehendra dilator; Cook Medical), and/or a 4-mm-diameter dilating balloon (Hurricane; Boston Scientific, Natick, Mass). Finally, a newly designed 8F plastic stent approved for use in
The guidewire was passed across the major papilla for the subsequent procedure. After tract dilation, endoscopic papillary balloon dilation (12-15 mm in diameter) was performed in an antegrade fashion. Common bile duct stones were extracted in an antegrade fashion by using a balloon retrieval catheter. Finally, an 8F plastic stent was placed in the extrahepatic bile duct above the papilla. The primary endpoint of this study was technical success and the secondary endpoint was adverse events. Technical success was defined as stent placement in the bile duct. Treatment success was defined as complete resolution of obstructive jaundice, stone removal, resolution of strictures, and/or resolution of clinical symptoms. Adverse events possibly related to the procedure were described according to the ASGE lexicon.12 All data were collected and taken care by only fixed endoscopists ( J.U., chief; K.I., S.T., N.I., K.K., R.T., R.T., and M.H., cooperators). For follow-up, in patients with bile duct stones, we scheduled stent removal in 1 or 2 months after the initial EUS-HGS. In patients with malignant obstruction, we did not schedule a regular stent exchange procedure but carried out the following procedure as needed. The guidewire (0.025-inch VisiGlide) was advanced in the common bile duct alongside the plastic stent (parallel cannulation
www.giejournal.org
Volume 82, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 391
Stent The plastic stent, which is a push-type stent and is usually not possible to retract, has a total length of 20 cm, an effective length of 15 cm, and 4 flanges (2 at the distal end and 2 at the proximal end). The proximal end has a pigtail structure and the distal end is tapered (Fig. 2).
Biliary stricture cases
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Umeda et al
Figure 2. The new plastic stent designed for EUS- hepaticogastrostomy stenting. Tapered tip and 4-fold–flanged single-pigtail bile duct stent (total length: 20 cm; effective length: 15 cm; flanges: 4 with apertures, side holes, total of 12 holes, distal straight site, 4 holes and pigtail site, 8 holes [Gadelius Medical Co, Ltd, Tokyo, Japan]).
Figure 3. Actual case presentation of EUS-hepaticogastrostomy stenting. The bile duct (segment 3) puncture was performed with a 19-gauge needle (A). A 0.025-inch guidewire was introduced through the EUS needle and advanced in an antegrade fashion (B). An 8F new plastic stent was placed in the bile duct. The site of the distal tip of the stent was the common bile duct (C). Endoscopic imaging of the proximal pigtail stent end (D).
technique) from the punctured gastric site by using a therapeutic duodenoscope and a tapered catheter. Then, the stent was removed by using snare forceps and rat-tooth grasping forceps, leaving the guidewire in place. Subsequently, a new stent was placed. CT was performed when stent occlusion and migration were suspected during the follow-up period. All patients provided written informed consent before the procedure. The study was approved by the institutional
review board of our hospital (no. 2503). This trial was registered at UMIN (UMIN000012993).
392 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
www.giejournal.org
RESULTS Twenty-three patients (median age, 77 years; 15 men) underwent EUS-HGS stenting (Fig. 3). Patient characteristics are summarized in Table 1. The reasons for requiring EUS-
Umeda et al
Newly designed plastic stent for EUS-guided hepaticogastrostomy
TABLE 1. Patient characteristics
Age, y/sex
Primary diseases
Reason for EUS-HGS
Altered anatomy
Stricture site
Previous ERCP attempt
Bilirubin level, mg/dL
1
73/F
CBD stone
Altered anatomy
TGþR-Y
d
Yes
0.47
2
65/M
Ampullary cancer
Periampullary tumor invasion
d
Bi
No
3.01
3
78/M
CBD stone
Failed duodenal intubation
Post-DP
d
Yes
0.5
4
58/M
Postoperative stricture
Previous ERCP failure
Billroth I, Lap-c
CHD
Yes
3.93
5
83/M
Pancreatic cancer
Failed duodenal intubation
Post DP
Bi
Yes
6.71
6
83/F
Pancreatic cancer
Altered anatomy
TGþR-Y
Bi
Yes
7.55
7
63/M
Pancreatic cancer
Altered anatomy
Choledochojejunostomy
Anastomosis
No
0.72
8
89/F
Pancreatic cancer
Periampullary tumor invasion
d
Bi
Yes
2.5
9
61/M
Postoperative stricture
Altered anatomy
Post Lap-PD
Anastomosis
No
0.79
10
78/F
Metastatic lymph nodes
Failed duodenal intubation
Post GJ þ Braun
Bi
Yes
8.85
11
68/M
Bile duct cancer
Previous ERCP failure
d
Bs
Yes
2.06
12
46/M
Pancreatic cancer
Periampullary tumor invasion
GJ
Bi
Yes
19.76
13
58/M
Pancreatic cancer
Periampullary tumor invasion
GJ
Bi
No
0.76
14
81/M
Pancreatic cancer
Periampullary tumor invasion
GJ þ cholecystojejunostomy
Bi
No
0.99
15
79/F
Pancreatic cancer
Previous ERCP failure
d
Bi
Yes
9.48
16
53/F
Pancreatic cancer
Periampullary tumor invasion
d
Bi
Yes
0.63
17
90/F
CBD stone
Altered anatomy
Billroth II
Bi
Yes
2.11
18
76/M
Pancreatic cancer
Periampullary tumor invasion
d
Bi
Yes
17.21
19
78/M
Bile duct cancer
Previous ERCP failure
d
Bi
Yes
17.53
20
81/M
CBD stone
Altered anatomy
TGþR-Y
d
Yes
1.78
Case
21
66/M
CBD stone
Altered anatomy
TG þ jejunal interposition
d
Yes
4.42
22
80/M
Ampullary cancer
Periampullary tumor invasion
d
Bi
No
1.35
23
82/M
Duodenal cancer
Periampullary tumor invasion
d
Bi
Yes
3.9
EUS-HSG, EUS-guided hepaticogastrostomy; F, female; CBD, common bile duct; TGþR-Y, total gastrectomy þ Roux-en-Y gastric bypass; M, male; Bi, inferior site of extrahepatic bile duct; DP, distal pancreatectomy; Lap-c, laparoscopic-cholecystedomy; CHD, common hepatic duct; Lap-PD, laparoscopic pancreatoduodenectomy; GJ þ Braun, gastrojejunostomy with Braun anastomosis; Bs, superior site of extrahepatic bile duct.
HGS were periampullary tumor invasion (n Z 9), altered anatomy (n Z 7), failed duodenal intubation (n Z 3), and prior ERCP failure (n Z 4). The outcomes of EUS-HGS stenting are shown in Table 2. The mean intrahepatic bile duct diameter measured by EUS at the time of puncture was 5.5 mm (range 2.5-10 mm). A 19-gauge needle (Video 1, available online at www.giejournal.org) and a 22-gauge needle (Video 2, available online at www.giejournal.org) were used in 14 patients and 9 patients, respectively. Bleeding
(not pulsating but oozing) from the punctured gastric wall occurred in 1 patient 3 days postoperatively with a decrease in the hemoglobin level (from 11.9 mg/dL to 10.5 mg/dL) and without the need for a blood transfusion. We exchanged the plastic stent for a fully covered selfexpandable metal stent (8 mm in diameter; WallFlex, Boston Scientific Japan, Tokyo, Japan). In this case, a 4-mm dilating balloon after tract dilation by using a cautery dilator was used. Hemostasis was achieved by metal stent placement,
www.giejournal.org
Volume 82, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 393
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Umeda et al
TABLE 2. Outcome of EUS-guided hepaticogastrostomy stenting Acute adverse events* (severity grade*)
Procedure Punctured BD Needle, Tract Technical duration, Case diameter, mm gauge dilation, mm success min
Stent Scheduled stent occlusion exchange or (time to removal (time to Stent FU Treatment occlusion), exchange or patency, duration, success mo removal), mo moy moz
1
10
19
CDþDB
Yes
30
No
Yes
No
Removal, 2
2
11
2
8
19
DB
Yes
10
Abdominal pain (mild)
Yes
No
Exchange, 4
4
8
3
5
22
DC
Yes
35
No
Yes
No
No
1.5x
1.5
4
5
19
CDþDB
Yes
15
Yes
N/A
N/A
N/A
10
5
5
22
DC
Yes
25
No
Yes
Yes (2)
N/A
2
5
6
6
22
CDþDB
Yes
16
No
Yes
No
No
4
4
7
6
22
CDþDB
Yes
20
No
Yes
No
No
4.5
4.5
8
10
19
DC
Yes
30
No
Yes
No
No
8
8
9
4
19
DC
Yes
20
No
Yes
No
Exchange (2.5)
2.5
12.5
Bleeding (moderate)
10
6
19
DC
Yes
16
No
Yes
No
No
0.5x
0.5
11
4.5
22
CD
Yes
20
No
Yes
No
No
7.5
7.5
12
2.5
22
DB
Yes
38
No
Yes
No
No
9
9
13
9
19
CDþDC
Yes
10
Abdominal pain (mild)
Yes
No
No
2.5x
2.5
14
4.5
22
CD
Yes
33
No
Yes
No
No
4
4
15
9
19
DC
Yes
25
No
Yes
Yes (3)
N/A
3
6.5
16
9
19
CDþDB
Yes
9
Abdominal pain (mild)
Yes
No
No
4
4
17
5
19
DC
Yes
23
No
Yes
No
No
4
4
18
9
19
CD
Yes
19
No
Yes
No
No
4
4
19
8
22
CD
Yes
24
No
Yes
No
Removal (1k)
1
5
20
2.5
22
DC
Yes
26
No
Yes
No
No
4.5
4.5
21
5
19
DC
Yes
63
No
Yes
No
Removal (2)
2
6
22
5
19
CD
Yes
10
No
Yes
No
No
4.5
4.5
23
6
19
CD
Yes
22
No
Yes
Yes (0.8)
N/A
0.8
7
BD, Bile duct; FU, follow-up; CDþDB, cautery dilator þ dilating balloon catheter; DC, dilation catheter; N/A, not applicable. *According to American Society for Gastrointestinal Endoscopy lexicon. yStent patency: 4 months (median), range 0.5-9. zFollow-up duration: 5 months (median), range 0.5-12.5. xPatent until death. kDuration until surgery.
and rebleeding did not occur. A mild adverse event of selflimited abdominal pain occurred in 3 patients. The technical success rate was 100%, and the mean procedure time was 22.8 minutes. Treatment success was achieved in all patients. Total bilirubin was normalized in all patients with obstructive jaundice (n Z 14, total bilirubin O2.0 mg/dL). The stent occlusion rate was 13.7% (3/22) during the follow-up period (median 5.0 months, range 0.5-12.5 months). The median duration of stent patency was 4.0 months (range 0.5-9.0 months). Scheduled stent exchange was performed in 2 patients and stent removal in 3 patients. In 3 patients, stent
obstruction occurred within 2 months and required stent exchange (Fig. 4; Videos 3 and 4, available online at www. giejournal.org); however, there was no stent migration or dislocation during the follow-up period.
394 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
www.giejournal.org
DISCUSSION EUS-HGS was first reported by Giovanini et al3 in 2003. Since then, it has become an alternative to percutaneous transhepatic biliary drainage or surgery after failed ERCP
Umeda et al
over the past decade (Supplementary Tables 1 and 2). To date, existing ERCP plastic or metal biliary stents, particularly straight-tip plastic stents at the early stage, have been used for EUS-HGS stenting (Supplementary Table 1). However, the current plastic stent was not ideal for EUS-HGS because its tip ( bile duct side) was not tapered. This reduced the straightening stability of the stent. The shape of the proximal end of the stent (gastric side) was straight with tiny flanges. The stent had the possibility of migrating into the abdominal cavity. Thus, we designed a new plastic stent dedicated for EUSHGS with these advantages: (1) the tapered and straight distal tip can be easily advanced in the liver and bile duct via the needle tract; (2) the 4 flanges and pigtail anchor of the stent can prevent proximal and distal stent migration, particularly on the gastric side; (3) a 15-cm effective stent length can be used for all patients regardless of their surgically altered anatomy; (4) relatively large apertures below the flanges and the 4 small holes in the distal end of the stent improve ductal drainage if the bile is turbid or concentrated like pus; (5) the absence of a hole in the middle part of the stent can prevent bile leakage into the peritoneal cavity; (6) a diameter of 8F can prevent left intrahepatic bile duct occlusion. In fact, our results showed that the stent could be easily placed in all cases (100%). Obstructive jaundice improved in all patients. In this study, we clarified the feasibility and effectiveness of this newly developed plastic stent for EUS-HGS. Bories et al9 reported that a covered metal stent (CMS) may be more preferable than a plastic stent. Theoretically, a CMS has the following potential advantages: (1) it affords better drainage owing to a larger bore stent than a plastic stent; (2) it prevents bile leakage and bile peritonitis13; and (3) it prevents bleeding from the tract due to a self-expandable stent. However, current CMSs may also have several disadvantages as follows: (1) they are more expensive than plastic stents, (2) popular CMSs worldwide are all braided-type stents, which show a high shortening rate of more than 40% and have a risk of fatal adverse events such as unexpected stent migration,11 although some CMSs do not foreshorten; (3) stent-related occlusion of the left intrahepatic bile ducts is possible; (4) overdilation of the narrow bile duct is possible. Of these disadvantages, difficulty of stent placement, particularly stent deployment by using a braided-type CMS is always problematic during EUSHGS. However, it has been reported in the literature that there is no obvious difference in the EUS-HGS outcome between a plastic stent and a metal stent (Table 3). Thus, a commercial dedicated CMS for EUSHGS is anticipated in the near future. Based on the characteristics of plastic stents and CMSs, we believe that stent selection depends on the patient’s condition (eg, benign or malignant), prognosis, and bile duct diameter. This may be similar to the strategy of transwww.giejournal.org
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Figure 4. Actual case presentation of stent exchange. The 0.025-inch guidewire was advanced in the common bile duct alongside the plastic stent (parallel cannulation technique) from the punctured gastric site using a therapeutic duodenoscope and a tampered catheter (A, endoscopic image, B, fluoroscopic image). Then, the stent was removed using a snare forceps, leaving the guidewire in place (C).
papillary stenting during ERCP. The newly designed plastic stent can therefore potentially contribute to a more reliable EUS-HGS procedure in selected patients. In this study, adverse events were observed in 17.4% (4/23) patients, which is comparable to those of previous single-center reports.10 The single moderate and 3 mild adverse events required no additional interventions except for the 1 case of bleeding. For the case of bleeding, a 4-mm dilating balloon was used after tract dilation by using a cautery dilator. Thereafter, only an 8F dilation catheter was used if needed after tract dilation with a cautery dilator. Further postprocedural bleeding was not observed. Caution was always taken to avoid overdilation of the tract beyond the stent diameter so as not to cause bile leakage. As a limitation, this preliminary study was performed at a single center with a small number of patients and without a control group. In conclusion, we designed a new single-pigtail plastic stent dedicated for EUS-HGS and confirmed its technical feasibility and clinical effectiveness. This plastic stent can possibly be used for highly selected patients with advanced malignancy or benign stricture. Additional long-term studies involving a sufficient number of patients are warranted. Volume 82, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 395
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Umeda et al
TABLE 3. Summary of medical literature of EUS-HGS when using plastic stents and metal stents* Stent
No.
Technical success rate, %
Clinical success rate, %
Adverse event rate, %
Mortality rate, %
Plastic stent
26
100 (26/26)
94.7 (18/19)
15.4 (4/26)
0.038 (1y/26)
Metal stent
147
95.2 (140/147)
91.6 (98/107)
16.3 (24/147)
0.007 (1z/134)
Current plastic stent
23
100 (23/23)
100 (23/23)
17.4 (4/23)
0
*Details are given described in Supplementary Tables 1 and 2. yOne patient who had septic shock before the first procedure died 4 days after procedure. zDue to stent migration.
ACKNOWLEDGMENTS The authors thank Dr Edward Barroga, Associate Professor and Senior Medical Editor, Tokyo Medical University, for editing the manuscript.
REFERENCES 1. Itoi T, Sofuni A, Itokawa F, et al. Endoscopic ultrasonography-guided biliary drainage. J Hepatobiliary Pancreat Sci 2010;17:611-6. 2. Itoi T, Tsuyuguchi T, Takada T, et al. TG 13 indications and techniques for biliary drainage in acute cholangitis (with videos). J Hepatobiliary Pancreat Sci 2013;20:71-80. 3. Giovanini M, Dotti M, Boris E, et al. Hepaticogastrostomy by echoendoscopy as a palliative treatment in a patient with metastatic biliary obstruction. Endoscopy 2003;35:1076-8. 4. Will U, Thieme A, Fueldner F, et al. Treatment of biliary obstruction in selected patients by endoscopic ultrasonography (EUS)-guided transluminal biliary drainage. Endoscopy 2007;39:292-5. 5. Burmester E, Niehaus J, Leineweber T, et al. EUS-cholangio-drainage of the bile duct: report of 4 cases. Gastrointest Endosc 2003;57:246-51.
396 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
6. Kahaleh M, Hernandez AJ, Tokar J, et al. Interventional EUS-guided cholangiography: evaluation of a technique in evolution. Gastrointest Endosc 2006;64:52-9. 7. Park DH, Koo JE, Oh J, et al. Endoscopic ultrasound-guided choledochoduodenostomy in patients with failed endoscopic retrograde cholangiopancreatography. World J Gastroenterol 2008;14: 6078-82. 8. Artifon EL, Chaves DM, Ishioka S, et al. Echoguided hepaticogastrostomy: a case report. Clinics 2007;62:799-802. 9. Bories E, Pesenti C, Caillol F, et al. Transgastric endoscopic ultrasonography-guided biliary drainage: results of pilot study. Endoscopy 2007;39:287-91. 10. Iwashita T, Doi S, Yasuda I. Endoscopic ultrasound-guided biliary drainage: a review. Clin J Gastroenterol 2014;7:94-102. 11. Martins FP, Rossini LG, Ferrari AP. Migration of a covered metallic stent following endoscopic ultrasound-guided hepaticogastrostomy: fatal complication. Endoscopy 2010;42(Suppl 2):E126-7. 12. Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:746-54. 13. Khashab MA, Valeshabad AK, Modayil R, et al. EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos). Gastrointest Endosc 2013;78:734-41.
www.giejournal.org
Umeda et al
Newly designed plastic stent for EUS-guided hepaticogastrostomy
SUPPLEMENTARY TABLE 1. Summary of medical literature of EUS-HGS when using plastic stents
Ref. Burmester1 2
No.
Puncture
Dilation method
Technical success rate, %
Clinical success rate, %
Adverse event rate, %
Mortality rate, %
1
FT
None
100
100
0
0
Giovanini
1
19G
NK
100
N/A
0
0
Kahaleh3
2
19G, 22G
N/A
100
100
0
0
Bories4
7
19G, 22G
Cystotome
100
100
5
19G
DC, DB
100
80
Horaguchi5 6
29 (2/7) (1 stent occlusion, 1 ileus) 0
0 0
Iwamuro
2
NK
DC
100
100
50 (1/2) (1 bile leak)
0
Ramirez-Luna7
2
19G
NK, DC
100
100
50 (1/2) (1 stent migration)
100% (1*/2)
Park8
6
19G
NK, DC
Total
26
100
NA
0
0
100% (26/26)
94.7% (18/19)
15.4% (4/26)
0.038% (1/26)
HGS, Hepaticogastrostomy; FT, fistulotomy; 19G/22G, 19-gauge/22-gauge FNA needle; NK, needle-knife; N/A, not applicable; DC, dilating catheter; DB, dilating balloon. *Patient who had septic shock before the first procedure died 4 days after procedure. 1.Gastrointest Endosc 2003;57:246-51. 2.Endoscopy 2003;35:1076-8. 3.Gastrointest Endosc 2006;64:52-9. 4.Endoscopy 2007;39:287-91. 5.Dig Endosc 2009;21:239-44. 6.Dig Endosc 2010;22:236-40. 7.Endoscopy 2011;43:826-30. 8.Gastrointest Endosc 2011;74:1276-84.
www.giejournal.org
Volume 82, No. 2 : 2015 GASTROINTESTINAL ENDOSCOPY 396.e1
Newly designed plastic stent for EUS-guided hepaticogastrostomy
Umeda et al
SUPPLEMENTARY TABLE 2. Summary of medical literature of EUS-HGS when using metal stents
No.
Access method
Dilation method
Stent
Technical success rate (%)
Clinical success rate, %
Adverse event rate, %
Mortality rate, %
1
19G
None
CMS
100
100
0 (0/1)
0
Will
4
19G
DC, DB
CMS
100
75
50 (2/4) (1 abdominal pain, 1 cholangitis)
0
Bories3
3
19G, 22G
Cystotome
CMS
100
100
67 (2/3) (2 migration)
0
Park4
8
19G
DC, NK
FCMS
100
100
0 (0/8)
0
Martins5
1
19G
NK
PCMS
100
N/A
100 (1/1) (1 migration)
100 (1/1)
Ref. Arifon1 2
Park6
5
19G
DC, NK
FCMS
100
100
0 (0/5)
0
Park7
25
19G
DC, NK
FCMS
100
N/A
24 (6/25) (N/A)
0
Fabbri8
1
19G
NK, DB
PCMS
0
d
0 (0/1)
d
Kim9
4
19G
DC, NK
FCMS
75
67
25 (1/4) (1 migration)
0
Tonozuka
3
19G
DC, DB
FCMS
100
N/A
0 (0/3)
0
Bapaye11
5
19G
CMS
60
N/A
33 (1/3) (1 peritonitis)
N/A
Ogura12
20
19G
SC
FCMS, PCMS
100
100
10 (2/20) (1 migration, 1 peritonitis)
0
Paik13
28
19G
SC, DB, NK
FCMS
96
89
0 (0/27)
0
Song14
10
19G
DC, NK
PCMS
100
100
Hamada15
4
19G
SC, DB, cystotome
CMS
75*
N/A
25 (1/4) (bleeding)
N/A
Artifon16
25
19G
DC, NK
PCMS
96
91
20 (5/25) (bacteremia 1, biloma 2, bleeding 3)
0
Total
147
95.2% (140/147)
91.6% (98/107)
16.3% (24/147)
0.007% (1/134)
10
DC, DB, cystotome, NK
30 (3/10) (1 bleeding, 2 pneumoperitoneum)
0
HGS, Hepaticogastrostomy; 19G/22G, 19-gauge/22-gauge fine-needle aspiration needle; CMS, covered metal stent; DC, dilating catheter; DB, dilating balloon; NK, needle-knife; FCMS, fully covered metal stent; N/A, not applicable; PCMS, partially covered metal stent; SC, standard catheter. *One case was a misplaced metal stent, but was subsequently managed by placing another metal stent in a tandem fashion. 1.Clinics (Sao Paulo) 2007;62:799-802. 2.Endoscopy 2007;39:292-5. 3.Endoscopy 2007;39:287-91. 4.Am J Gastroenterol 2009;104:2168-74. 5.Endoscopy 2010;42(Suppl 2):E126-7. 6.Gastrointest Endosc 2010;71:413-9. 7.Gastrointest Endosc 2011;74:1276-84. 8.Endoscopy 2011;43:438-41. 9.World J Gastroenterol 2012;18:2526-32. 10.Dig Endosc 2013;25(Suppl 2):100-8. 11.United Eur Gastroenterol J 2013;1:285-93. 12.J Gastroenterol Hepatol 2014;29:1815-21. 13.World J Gastroenterol 2014;20:5051-9. 14.Gastrointest Endosc 2014;80:707-11. 15.Dig Dis Sci 2014;59:1931-8. 16.Gastrointest Endosc 2014 Dec 12.
396.e2 GASTROINTESTINAL ENDOSCOPY Volume 82, No. 2 : 2015
www.giejournal.org