Endosonography-guided transmural drainage of pancreatic pseudocysts using an exchange-free access device: initial clinical experience
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- Binmoeller, K.F., Weilert, F., Shah, J.N. et al. Surg Endosc (2013) 27: 1835. doi:10.1007/s00464-012-2682-9
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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.
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.
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.
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.
KeywordsEndoscopic 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.
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.
Data on patients (n = 14) and pseudocysts (n = 16)
Males: n (%)
Average age: years (range)
Etiology of pancreatitis
Average cyst size: mm (range)
Stent exchange: n (%)
Cyst resolution: n (%)
Mean follow-up period: weeks (range)
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 .
Prior reports have described prototype devices developed to combine the steps of access, dilation, and drainage. Seewald et al.  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.  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 , a 10-Fr Soehendra dilator , and an 8-Fr Haber Ramp .
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.
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.
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