Surgical Endoscopy

, Volume 27, Issue 5, pp 1835–1839

Endosonography-guided transmural drainage of pancreatic pseudocysts using an exchange-free access device: initial clinical experience

  • Kenneth F. Binmoeller
  • Frank Weilert
  • Janak N. Shah
  • Yasser M. Bhat
  • Steve Kane
Dynamic Manuscript

DOI: 10.1007/s00464-012-2682-9

Cite this article as:
Binmoeller, K.F., Weilert, F., Shah, J.N. et al. Surg Endosc (2013) 27: 1835. doi:10.1007/s00464-012-2682-9

Abstract

Background

Endosonography (EUS)-guided transmural pseudocyst drainage is a multistep procedure currently performed with different “off-the-shelf” accessories developed for other applications. Multiple device exchanges over-the-wire is time consuming and risks loss of wire access. This report describes the technical feasibility and outcomes for EUS-guided drainage of pancreatic fluid collections using a novel exchange-free device developed for translumenal therapy.

Methods

Between April and November 2010, 14 patients (9 men; mean age, 49.9 years) with pancreatic fluid collection (mean size, 102 mm) underwent 16 EUS-guided drainage procedures using the exchange-free access device at a single tertiary care center. The trocar of the exchange-free device was used to gain pseudocyst access. The dual-balloon catheter then was advanced over the trocar, followed by inflation of the (first) anchor balloon. Cyst contents were sampled, and contrast was injected to define the pseudocyst anatomy. The first guidewire was inserted into the cyst cavity. The cystenterostomy tract was dilated to 10 mm with the (second) dilation balloon, followed by a second guidewire insertion. The exchange-free access device was removed, leaving the two guidewires in place for two double-pigtail stents.

Results

The procedure was technically successful for all the patients. No acute procedure-related complications occurred. Late complications included a symptomatic leak in a patient who underwent drainage of a pancreatic uncinate pseudocyst from the second duodenum, a self-limited transfusion-dependent bleed after transbulbar drainage, and symptomatic pseudocyst infection.

Conclusion

Pseudocyst access, cystenterostomy tract dilation, and placement of two guidewires for dual stent drainage are technically feasible using an exchange-free access device. The device has the potential to standardize, simplify, and streamline EUS-guided pseudocyst drainage with a single instrument. Comparative studies with alternative tools and methods for pseudocyst drainage are warranted.

Keywords

Endoscopic ultrasonography Endosonography Pseudocyst drainage Exchange-free access device Cystenterostomy 

Endoscopic ultrasound (EUS)-guided pseudocyst drainage currently is performed with “off-the-shelf” tools developed for other applications. The procedure remains technically challenging, requires multiple device exchanges, and is time consuming. Because the tools and the technique used are not standardized, a comparison of treatment outcomes in studies is limited. We report on the use of a single “exchange-free” device for EUS-guided drainage of pancreatic fluid collections. This pilot study evaluated the technical feasibility and outcomes of drainage using this device.

Methods

Patients who underwent EUS-guided pseudocyst drainage per a standardized clinical protocol at a single institution were identified in a retrospective review of a prospectively computerized database (Provation Medical, Minneapolis, MN, USA). All the patients had symptomatic pseudocysts with liquid contents exceeding 70 % and evidence of adherence between the pseudocyst and the enteric wall at EUS examination. The procedures were performed by one of two endoscopists (K.F.B., J.N.S.) experienced in EUS-guided pseudocyst drainage under monitored anesthesia sedation. Parenteral antibiotics were administered before the procedure. Our institutional review board approved this study.

The exchange-free access device (NAVIX; Xlumena Inc., Mountain View, CA, USA), cleared by the Food and Drug Administration (FDA) in April 2010, comprises an endoscopic trocar with a blade that creates a 3.5-mm puncture opening, an anchor balloon that maintains access within the target, a dilation balloon that expands the tract to 10 mm, and two guidewire ports (Fig. 1A, B). Radiopaque and endoscopic markers on the shaft indicate the location of the proximal and distal ends of the balloon as well as the location of the second guidewire exit port (Fig. 1B). The device handle Luer fits onto the inlet port of the working channel of a curved-linear-array echoendoscope (Fig. 1A).
Fig. 1

A. Overview of the Navix device. At the handle end, separate ports (arrows) are used to inflate the anchor (B1) and dilation (B2) balloons with an inflation device. The balloon catheter is advanced using a rotating knob (R). The depth of trocar advancement is set with the trocar depth collar (T). The handle is Luer-fitted (L) onto the echoendoscope working channel inlet port. B. Close up of the distal end of the device showing the deployed trocar blade (TB) after advancement of the trocar from the catheter sheath, and inflated 8 mm anchor balloon (B1), and the 10 mm dilation balloon (B2). Exit port for the second guidewire (GW). Two black band markers on the catheter shaft, each 7.5 mm in length (totaling 2 cm from proximal to distal ends of the bands), are located proximal to the second guidewire exit port

Study procedures

The procedures were performed using 3.7-mm-channel curved-linear-array echoendoscopes (Olympus, Center Valley, PA, USA). The endoscopic trocar on the exchange-free access was used to gain EUS-guided transgastric or transduodenal access into the pseudocyst (Fig. 2). The balloon catheter was advanced directly over the trocar, followed by inflation of the anchor balloon (Figs. 1B, 3A) to secure access. After aspiration of a diagnostic sample, dilute contrast was injected to outline the pseudocyst cavity fluoroscopically. One 0.035-in. guidewire (Jagwire; Boston Scientific, Natick, MA, USA, or Metrowire; Cook Endoscopy, Winston-Salem, NC, USA) was inserted into the cyst cavity (Fig. 3B).
Fig. 2

Endosonographic view showing transmural puncture of the pseudocyst with the trocar of the exchange-free device

Fig. 3

Fluoroscopic views after inflation of the anchor balloon (arrow) to secure access within the pseudocyst. A Contrast injection through the catheter sheath after trocar removal. B Insertion of a 0.035 inch guidewire into the pseudocyst and retraction of the anchor balloon to the pseudocyst wall

Fig. 4

Fluoroscopic view showing balloon dilation of the cystenterostomy tract to 10 mm. Insertion of a 0.035 inch guidewire into the pseudocyst and retraction of the anchor balloon to the pseudocyst wall

The cystenterostomy tract was dilated to 10 mm with the dilation balloon (Fig. 4). After the dilation, a second 0.035-in. guidewire was inserted through a second guidewire port under fluoroscopic and endoscopic guidance (Fig. 1B, GW). The exchange-free access device was removed from the echoendoscope, leaving the two guidewires in place. Two double-pigtail stents (7 Fr × 4 cm followed by 10 Fr × 3 cm, Cook Medical, Winston-Salem, NC, USA) were inserted in sequence across the cystgastrostomy tract for drainage (Fig. 5A, B). The patients were instructed to take daily oral antibiotics and to avoid all acid suppressive medication until pseudocyst resolution documented by contrast-enhanced computed tomography (CT). Stents were replaced if the pseudocyst failed to decrease in size after an interval of 2 weeks or longer. Cyst resolution was defined as a cyst smaller than 3 cm on interval CT.
Fig. 5

Endoscopic views of insertion of two double pigtail stents. A A 7 Fr × 4 cm double pigtail stent is first inserted alongside the second guidewire B A 10 Fr x 3 cm double pigtail stent is inserted over the second guidewire

Results

Between May 2010 and November 2010, 14 patients underwent 16 drainage procedures. The results and outcomes are summarized in Table 1. The complications included a symptomatic leak 48 h after stent placement in a patient who underwent drainage of a pancreatic uncinate process pseudocyst from the second duodenum. This patient underwent surgery and had an uneventful recovery. One patient experienced a delayed bleed after transbulbar drainage that responded to transfusions. Another patient experienced fever and an elevated white count after stent drainage and underwent percutaneous drainage at an outside hospital.
Table 1

Data on patients (n = 14) and pseudocysts (n = 16)

Males: n (%)

9 (64)

Average age: years (range)

49.9 (18–73)

Etiology of pancreatitis

 Gallstones

4

 Alcohol

7

 Drug-induced

1

 Post-ERCP

1

 Idiopathic

1

Average cyst size: mm (range)

102 (60–170)

Drainage route

 Transgastric

14

 Transduodenal

2

Complications

 Leak

1

 Bleeding

1

 Cyst infection

1

Stent exchange: n (%)

5 (36)

Cyst resolution: n (%)

11 (79)

Mean follow-up period: weeks (range)

13.1 (1.9–22.6)

ERCP endoscopic retrograde cholangiopancreatography

Discussion

Endosonography-guided translumenal pseudocyst drainage is a multistep procedure that is technically challenging and time consuming. The exchange of devices over the guidewire carries an inherent risk of loss of access. The exchange-free access device was developed to enable pseudocyst access, tract dilation, and dual guidewire placement without device exchange. The pilot data from the current study validate the technical feasibility of pseudocyst drainage using this device. The procedure was technically successful for all 14 patients and clinically success for 79 % on an intention-to-treat basis. Delayed complications occurred for three patients, with no mortality. One patient experienced a symptomatic leak after drainage of a pseudocyst from the distal duodenum, which we believe was due to inadequate adherence of the cyst to the duodenal wall.

Novel aspects of the exchange-free access device included a lumenless trocar made of nitinol. A lumen was not required because aspiration, injection, and guidewire placement occurred through the balloon catheter. Compared with a flexible guidewire, a solid trocar should provide a more stable platform than for coaxial transmural advancement of the balloon catheter.

Construction of the trocar from nitinol has the theoretical advantage of less stiffness and thus the ability to adjust the exit angle with the elevator for more perpendicular access to the pseudocyst. A blade at the end of the trocar deployed after its exit from the catheter sheath to create a 3.5-mm opening that facilitated subsequent advancement of the 10-Fr balloon catheter over the trocar. However, a potential drawback of creating a larger opening by blade incision is bleeding. Accordingly, we took precautions to avoid interposed vessels seen on Doppler ultrasound before puncture.

We found that the dual balloon catheter design provided several practical advantages. The anchor balloon remained inflated during the entire procedure, thus preventing accidental loss of cyst access. After removal of the trocar, we could aspirate cyst contents, inject contrast, and insert a guidewire through the catheter while keeping the anchor balloon inflated. The balloon also could be retracted to enforce apposition of the cyst wall against the enteric wall and to stabilize the position of the dilation balloon, countering the tendency for the balloon to slip forward or backward during dilation.

We successfully passed two standard 0.035-in. guidewires through the balloon catheter, through separately labeled ports at the handle end, for subsequent dual stent placement in all cases. Removal of the exchange-free access device over the two wires, however, would risk accidental withdrawal of the wires. It was helpful to lock the wires with the elevator and monitor stable wire position with fluoroscopy. The 3.7-mm working channel size (with guidewires in situ) limited the size of the first stent to 7 Fr, followed by a 10-Fr double-pigtail stent. We did not schedule patients for stent removal in light of a recent randomized study showing that patients who had stents retrieved had a higher cyst recurrence rate [1].

Prior reports have described prototype devices developed to combine the steps of access, dilation, and drainage. Seewald et al. [2] described a three-layer puncture kit prototype consisting of a 22-gauge electrocautery needle within an inner 5-Fr catheter and an outer 8.5-Fr catheter (ref). After entry into the pseudocyst, the needle and inner 5-Fr catheter are withdrawn, leaving the 8.5-Fr outer catheter in the cyst for insertion of two 0.035-in. guidewires.

Reddy et al. [3] described a “transluminal balloon accessotome” prototype for endoscopy-guided pseudocyst drainage that combines needleknife puncture and balloon dilation in a single step (ref). Placement of two guidewires after cyst access also has been reported using large bore catheters including a 10-Fr cystotome [4], a 10-Fr Soehendra dilator [5], and an 8-Fr Haber Ramp [6].

In summary, this pilot study demonstrated the technical feasibility of accomplishing cyst puncture, dilation, and dual guidewire placement with a single-exchange free device. The device has the potential to standardize, simplify, and streamline EUS-guided pseudocyst drainage. Larger studies with a control group are needed to determine whether this novel device improves efficacy, safety, and outcomes over those of other drainage techniques.

Disclosures

Kenneth F. Binmoeller is a consultant (chief medical officer) with an equity interest in Xlumena, Inc. Janak N. Shah is a consultant and advisory board member of Xlumena, Inc. Frank Weilert, Yasser Bhat, and Steve Kane have no conflicts of interest or financial ties to disclose.

Supplementary material

Supplementary material 1 (M4V 48416 kb)

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Kenneth F. Binmoeller
    • 1
  • Frank Weilert
    • 1
  • Janak N. Shah
    • 1
  • Yasser M. Bhat
    • 1
  • Steve Kane
    • 1
  1. 1.Paul May and Frank Stein Center for Interventional EndoscopyCalifornia Pacific Medical CenterSan FranciscoUSA

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