Case series

Initial evaluation of a new plastic pancreatic duct stent for endoscopic ultrasonography-guided placement

Authors

Takao Itoi1, Atsushi Sofuni1, Takayoshi Tsuchiya1, Kentaro Ishii1, Nobuhito Ikeuchi1, Reina Tanaka1, Junko Umeda1, Ryosuke Tonozuka1, Mitsuyoshi Honjo1, Shuntaro Mukai1, Takako Takayama2, Fuminori Moriyasu1

Institutions

1 2

submitted 26. July 2014 accepted after revision 7. October 2014

Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1391083 Published online: 15.1.2015 Endoscopy 2015; 47: 462–465 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Takao Itoi, MD, PhD Internal Medicine Tokyo Medical University 6-7-1 Nishi Shinjuku Shinjuku Tokyo 160-0023 Japan Fax: +81-3-53816654 [email protected]

Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan Department of Gastroenterology and Hepatology, Tokyo Women’s Medical University, Tokyo, Japan

There are currently no plastic pancreatic duct stents that have been designed for endoscopic ultrasonography (EUS)-guided placement. This study prospectively evaluated the feasibility and efficacy of a new, single-pigtail, plastic stent. Eight patients with main pancreatic duct stricture or stenotic pancreatojejunostomy underwent EUS-guided placement of the pancreatic duct

stent. The stent was placed successfully in all cases (8/8). Treatment success was achieved in all cases (8/8). A mild adverse event associated with the procedure was observed in one patient but there were no other adverse events during a mean follow-up of 7.4 months. This new pancreatic duct stent appears to be feasible and effective for EUS-guided stenting.

Introduction

trast medium by 19-G or 22-G fine needles, an insulated guidewire was advanced antegrade into the duct. When possible, the wire was passed across the pancreatic duct stricture and major papilla or pancreatojejunostomy. Dilation of the needle tract and anastomotic site was carried out using a standard or tapered catheter, cautery dilator (6.5 Fr; Endoflex, Voerde, Germany), or a 4-mm-diameter dilating balloon. Finally, a newly designed, 7-Fr, pancreatic duct stent was placed. The stent has a tapered tip, four internal flanges (two in the distal end and two at the proximal end), and a single external pigtail (total length of 20 cm and an effective length of 15 cm; Gadelius " Fig. 1, ● " Fig. 2). Medical Co., Ltd., Tokyo, Japan) (● When possible, the distal end of the stent was positioned across the papilla or anastomotic site. Otherwise, the distal end of the stent remained in the MPD and the proximal end remained in the stomach. Technical success was defined as stent placement in the MPD. Treatment success was defined as complete resolution of clinical symptoms. Adverse events possibly related to the procedure were identified within 30 days. All patients provided written informed consent for the procedure. The study was approved by the institutional review board of the hospital (no. 2503). The study was registered at UMIN (UMIN000012447).

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Acute recurrent pancreatitis (ARP) can occur as a result of pancreatic duct obstruction from any cause. Recently, endoscopic ultrasonography (EUS)-guided pancreatic duct stent placement has been used to treat such patients when traditional endoscopic retrograde cholangiopancreatography (ERCP) has failed or is not possible because of postsurgical anatomy [1 – 6]. In these previous reports [2 – 5], the mean technical success rate was only 82 %. Furthermore, adverse events such as pancreatic duct leaks, stent migration, and pancreatitis commonly occurred. We hypothesized that the low technical success and high adverse event rate may be due to lack of a dedicated pancreatic duct stent designed for EUS-guided placement. The aim of this study was to prospectively evaluate the feasibility and safety of a new, single-pigtail, plastic, pancreatic duct stent for EUS-guided placement.

Patients and methods !

Eight patients with ARP caused by main pancreatic duct (MPD) stricture or stenotic pancreatojejunostomy underwent EUS-guided pancreatic duct placement between August 2013 and May 2014 " Table 1). (● Therapeutic echoendoscopes were used with carbon dioxide insufflation. After injection of con-

Itoi Takao et al. Evaluation of novel pancreatic duct stent … Endoscopy 2015; 47: 462–465

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

462

Case series

Table 1

463

Patient characteristics.

Patient #

Age, years/sex

Indication

Postoperative anatomy

Stricture site

Prior ERP attempt

Maximum MPD

1

71/female

ARP

Pancreatoduodenectomy

Anastomosis

No

7.0

2

79/female

ARP

Pancreatoduodenectomy

Anastomosis

No

3.5

3

64/male

ARP

Pancreatoduodenectomy

Anastomosis

No

8.0

4

69/male

ARP

Pancreatoduodenectomy

Anastomosis

Yes

7.0

5

66/female

ARP

Middle pancreatectomy

MPD

Yes

9.5

6

57/female

ARP

STG + R-Y

MPD

Yes

10.0

7

35/female

ARP

Pancreatoduodenectomy

Anastomosis

Yes

2.5

8

61/male

ARP

Pancreatoduodenectomy

Anastomosis

Yes

4.0

diameter, mm

Fig. 1 New plastic pancreatic duct stent designed for endoscopic ultrasonography-guided placement. The stent has a total length of 20 cm and an effective length of 15 cm. The stent has four flanges; two in the distal end and two at the proximal end. A pigtail is present at the proximal end and the distal end is tapered. One side hole is present in the distal end (Gadelius Medical Co. Ltd., Tokyo, Japan).

" Fig. 3, ● " Video 1). The distal tip of the stent was positioned in (● the duodenum and jejunum when the guidewire could be passed across the stricture. The technical success rate was 100 %, and mean procedure time was 37.5 minutes. One mild adverse event of self-limited abdominal pain occurred. Treatment success was achieved in all patients. There were no other adverse events during a mean follow-up of 7.4 months.

Discussion !

Fig. 2 Schema of the new pancreatic duct stent in a patient with in postWhipple anatomy. The new stent is transgastrically placed into the pancreatic duct to the jejunum via the pancreatojejunostomy.

Results

This study reports the feasibility and efficacy of a new, plastic, pancreatic duct stent designed for EUS-guided placement. We believe that the new stent has several advantages: 1) the tapered and straight distal tip can be easily advanced via the needle tract and stricture sites; 2) the four flanges and pigtail anchor the stent and prevent outward and inward migration; 3) a 15-cm effective stent length can be used for all patients regardless of underlying anatomy; 4) relatively large apertures below the flanges and four small holes in the distal end of the stent improve ductal drainage; 5) the absence of a hole in the middle part of the stent may help to prevent pancreatic ductal leakage into the peripancreatic space (between the stomach and the pancreas).

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Eight patients (three men) with Whipple resection (n = 6), middle pancreatectomy (n = 1), and subtotal gastrectomy with Roux-en-Y reconstruction (n = 1) underwent EUS-guided pancreatic duct stenting. The strictures were found in the pancreatojejunostomy " Table 1). Five patients (62.5 %), had site (n = 6) and MPD (n = 2) (● previously undergone unsuccessful ERCP. The mean MPD diameter measured by EUS at the time of punc" Table 2). A 19-G needle ture was 3.2 mm (range 1.6 – 6.0 mm) (● was used in four patients and a 22-G needle was used in the remaining four patients. In all but two patients (#5 and #8), the guidewire was successfully advanced across the MPD stricture or anastomosis. All stents were easily advanced without difficulty

Video 1

Endoscopic ultrasound-guided pancreatic duct stent placement.

Online content including video sequences viewable at: www.thieme-connect.de

Itoi Takao et al. Evaluation of novel pancreatic duct stent … Endoscopy 2015; 47: 462–465

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

ARP, acute recurrent pancreatitis; ERP, endoscopic retrograde pancreatography; STG + R-Y, subtotal gastrectomy + Roux-en-Y; MPD, main pancreatic duct.

Case series

Table 2

Outcome of endoscopic ultrasonography-guided pancreatic duct stenting.

Patient

Punctured

Needle,

Guidewire

Tech-

Site of

Procedure

Acute

Treat-

Scheduled

Adverse

Follow-up

#

MPD diam-

G

passage1

nical

distal tip

duration,

adverse

ment

stent

events during

duration,

success

of stent

minutes

events

success

exchange

follow-up

months

eter, mm

period 1

3.5

22

Yes

Yes

Jejunum

33

No

Yes

Yes

No

8.0

2

1.6

22

Yes

Yes

Jejunum

30

Abdominal pain

Yes

Yes

No

7.0

3

3.2

19

Yes

Yes

Jejunum

19

No

Yes

Yes

No

13.0

4

3.6

19

Yes

Yes

Jejunum

16

No

Yes

Yes

No

7.5

5

2.5

19

No

Yes

MPD

54

No

Yes

Yes

No

10.5

6

6.0

19

Yes

Yes

Jejunum

26

No

Yes

Yes

No

10.5

7

2.2

22

Yes

Yes

Jejunum

70

No

Yes

No

No

1.0

8

3.0

22

No

Yes

MPD

52

No

Yes

No

No

2.0

MPD, main pancreatic duct. 1 Guidewire could advance the pancreatic duct stricture or anastomotic site, or not.

Fig. 3 Actual case presentation of endoscopic ultrasound (EUS)-guided pancreatic duct stent placement. a EUS showed a dilated pancreatic duct. b Pancreatogram showed obstruction of pancreatojejunostomy and pancreatic duct stones. c A new 7-Fr plastic stent was placed into the pancreatic duct to the jejunum via the pancreatojejunostomy. d Endoscopic imaging of the proximal pigtail stent end. PD, pancreatic duct.

A straight distal tip has improved ability to traverse strictures than a stent with a distal pigtail. In addition, a more tapered tip may provide better pushability than the standard pancreatic duct stents that are not tapered to the same extent. However, the straight distal stent tip may result in stent migration. To address this concern, the stent was designed with four distal flanges in combination with a pigtail at the gastric site. Although longterm outcomes are needed in order to evaluate the function of the flanges, the current study has shown that the design is sufficient to avoid stent migration after initial EUS-guided placement. The ideal length of an EUS pancreatic duct stent is not known [5]. In our experience, the distance between the puncture site and the major papilla or pancreatojejunostomy site may be longer than expected, depending on the puncture site. We believe a 15 cm

stent length is effective and suitable, although various stent lengths need to be available. The limitations of this study were the small sample size, lack of a control group, and the inclusion of only a single operator. In conclusion, the new pancreatic duct stent designed specifically for EUS placement was feasible and effective. Further studies involving multiple centers and a large number of cases are now warranted. Trial registration: UMIN000012447. Competing interests: None

Itoi Takao et al. Evaluation of novel pancreatic duct stent … Endoscopy 2015; 47: 462–465

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

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Case series

Acknowledgments

465

The authors are indebted to Ms. Maya Vardaman and Dr. Edward F. Barroga, Associate Professor and Senior Editor of the Department of International Medical Communications of Tokyo Medical University, Japan. We are also grateful to Dr. Todd. H. Baron of the University of North Carolina, Chapel Hill, USA, for his valuable editing suggestions.

1 François E, Kahaleh M, Giovannini M et al. EUS-guided pancreaticogastrostomy. Gastrointest Endosc 2002; 56: 128 – 133 2 Kahaleh M, Hernandez AJ, Tokar J et al. EUS-guided pancreaticogastrostomy: analysis of its efficacy to drain inaccessible pancreatic ducts. Gastrointest Endosc 2007; 65: 224 – 230 3 Tessier G, Bories E, Arvanitakis M et al. EUS-guided pancreatogastrostomy and pancreatobulbostomy for the treatment of pain in patients with pancreatic ductal dilatation inaccessible for transpapillary endoscopic therapy. Gastrointest Endosc 2007; 65: 233 – 241 4 Kurihara T, Itoi T, Sofuni A et al. EUS-guided pancreatic duct drainage in patients with failed ERCP. Dig Endosc 2013; 25: 02109 – 116 5 Fujii LL, Topazian MD, Abu Dayyeh BK et al. EUS-guided pancreatic duct intervention: outcomes of a single tertiary-care referral center experience. Gastrointest Endosc 2013; 78: 854 – 864 6 Itoi T, Kasuya K, Sofuni A et al. Endoscopic ultrasonography-guided pancreatic duct access: technique and literature review of pancreatography, transmural drainage and rendezvous techniques. Dig Endosc 2013; 25: 241 – 252

Itoi Takao et al. Evaluation of novel pancreatic duct stent … Endoscopy 2015; 47: 462–465

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

References

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Initial evaluation of a new plastic pancreatic duct stent for endoscopic ultrasonography-guided placement.

There are currently no plastic pancreatic duct stents that have been designed for endoscopic ultrasonography (EUS)-guided placement. This study prospe...
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