Modified endoscopic ultrasound-guided double-balloon-occluded gastroenterostomy bypass (M-EPASS): a pilot study

• Abstract
• Background
• Methods
• M-EPASS procedure description
• Study design and population
• Results
• Discussion
• References

Abstract

Introduction We recently developed a double-balloon device, using widely available existing technology, to facilitate endoscopic ultrasound-guided gastroenterostomy (EUS-GE). Our aim is to assess the feasibility of this modified approach to EUS-guided double-balloon-occluded gastroenterostomy bypass (M-EPASS).

Methods This was a single-center retrospective study of consecutive patients undergoing M-EPASS from January 2019 to August 2020. The double-balloon device consists of two vascular balloons that optimize the distension of a targeted small-bowel segment for EUS-guided stent insertion. The primary end point was the rate of technical success.

Results 11 patients (45 % women; mean [standard deviation (SD)] age 64.9 [8.6]) with malignant gastric outlet obstruction were included. Technical and clinical success (ability to tolerate an oral diet) were achieved in 91 % (10/11) and 80 % (8/10) of patients, respectively. There was one adverse event (9 %) due to stent migration. Two patients (18 %) required re-intervention for stent obstruction secondary to food impaction. The mean (SD) time to a low residue diet was 3.5 (2.4) days.

Conclusion M-EPASS appears to facilitate the technique of EUS-GE, potentially enhancing its safety and clinical adoption. Larger studies are needed to validate this innovative approach to gastric outlet obstruction.

Background

Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a novel technique associated with lower rates of stent dysfunction and consequently with improved palliation compared with traditional enteral stenting in patients with malignant gastric outlet obstruction (GOO) [1] [2]. The major limitation to its widespread clinical adoption is its technical difficulty and the associated risk of adverse events, including stent misdeployment, a feared and potentially fatal complication [3].

Although several methods have been described for EUS-GE [4], the use of a double-balloon occluding catheter (EPASS) has proven to be one of the more promising techniques, which facilitates stent insertion through stabilization and distension of the targeted small bowel. This device is not, however, available outside of Asia. Consequently, in North America and Europe, EUS-GE is most commonly performed using the direct water-infusion technique, which can be quite challenging and carries a significant risk of stent misdeployment [3]. Clinical adoption has therefore been appropriately modest, and EUS-GE has yet to become a practice-changing modality.

The aim of this study was to report the first North American experience with an occlusive double-balloon device, using a widely available vascular balloon catheter, for EUS-GE (a modified EPASS [M-EPASS] procedure). This simple, ubiquitous technology has the potential to simplify the technique of EUS-GE and optimize its safety, which are necessary steps toward increasing the clinical adoption of this modality.

Methods

The technical details of M-EPASS have previously been described in detail by our group [5]. To summarize, a vascular balloon catheter (Coda; Cook Medical, USA) used for occluding major vessels in interventional radiology is used as the balloon device. The catheter has a compliant balloon near its tip that measures 60 mm in diameter on maximal inflation. The catheter has three lumens: one for wire passage (0.035 inch), another for fluid infusion at the tip of catheter, and one for inflation of the balloon. To replicate the specialized enteric double-occlusive-balloon catheter described by Itoi et al. [6] , two Coda balloon catheters were fashioned together using waterproof zinc oxide adhesive tape at multiple segments of the device, with the balloons 15 cm apart (Fig. 1s, see online-only Supplementary Material).

M-EPASS procedure description

M-EPASS is performed with the patient under either endoscopist-directed conscious sedation (EDCS) or general anesthesia. An endoscope is inserted orally through an overtube to the level of the obstruction and a 0.035-inch guidewire is advanced across the obstruction into the jejunum ([Video 1]). The endoscope is then removed and the dual-balloon catheter is advanced over the wire and through the overtube under fluoroscopic guidance until the distal balloon is beyond the ligament of Treitz. The balloons are then inflated to 60 mm with contrast and the overtube is removed. Saline and contrast are infused between the occluding balloons to distend the targeted small-bowel segment (Fig. 2s). This segment is identified via EUS from the stomach. A 15-mm lumen-apposing metal stent (LAMS; Axios, Boston Scientific Inc., USA) is then inserted freehand with cautery assistance and deployed under sonographic guidance.

Video 1 The modified endoscopic ultrasound-guided double-balloon-occluded gastrojejunostomy bypass (M-EPASS) procedure.

All patients are started on a clear fluid diet on the evening of the procedure and progress to a low residue diet over the following 48–72 hours.

Study design and population

This was a single-center retrospective study of consecutive patients undergoing EUS-GE using M-EPASS for malignant GOO from January 2019 to August 2020. The primary end point was the rate of technical success, defined as adequate deployment of the LAMS, confirmed via a combination of endoscopy, sonography, and fluoroscopy. Secondary end points included the rates of clinical success using a per-protocol approach and adverse events, as defined by the American Society for Gastrointestinal Endoscopy (ASGE) lexicon [7].

Results

A total of 11 patients (45 % women; mean [standard deviation (SD)] age 64.9 [8.6] years) were included in this study (Table 1s). All patients reported nausea and vomiting as their primary symptom. The most common etiologies of malignant GOO were other metastatic cancer (73 %), gastric cancer (9 %), duodenal cancer (9 %), and metastatic cancer (9 %). Procedures were performed with the patient under general anesthesia or EDCS in 82 % and 18 % of patients, respectively. The mean (SD) procedure time was 64.8 (25.8) minutes. Technical success was achieved in 91 % of patients (10/11). The only technical failure was due to poor patient tolerability of the procedure under EDCS, which was converted successfully to a duodenal stent. Clinical success was achieved in 80 % (8/10), with one patient being unable to tolerate a low residue diet, thought to be secondary to gastroparesis, while another had stent migration shortly after the procedure.

There was one adverse event (9 %) due to stent migration and this was rated as severe. This occurred in an obese individual 1 day after the EUS-GE. The patient stood upright and reported acute abdominal pain. A computed tomography (CT) scan showed that the small bowel had pulled away from the distal flange of the LAMS. The patient was immediately brought to the operating room. During laparotomy, it was discovered that the LAMS had traversed through the mesentery proximally to the small bowel (Fig. 3s). Migration had likely occurred owing to the gravitational pull of the mesentery as it dropped down when the patient stood up. The patient recovered uneventfully following LAMS removal and conversion to a surgical gastroenterostomy.

Two other patients (18 %) required re-intervention for stent obstruction secondary to food impaction associated with non-compliance with the low residue diet. Following re-enforced instructions, no further obstructions occurred.

All patients started a liquid diet within 1 day of the procedure, with a mean (SD) time to low residue diet of 3.3 (2.5) days. The median follow-up time was 84 days (interquartile range 152 days).

Discussion

Despite its impressive clinical results in malignant GOO [1] [2] [3] [6], the adoption of EUS-GE has been limited in clinical practice. Indeed, more than half a decade following its first description, the technique has not moved beyond the walls of the most expert centers and remains in the developmental stages (phase 2a) of a technology’s lifecycle [8]. Conversely, although it employs the same stent, EUS-guided drainage of pancreatic fluid collections has seen a relative “explosion” of uptake since LAMSs became available [9]. This discrepancy is likely due to the technical challenges and high risk nature of EUS-GE. The EPASS method has the potential to improve the accessibility of EUS-GE by relatively fixing in place and distending the small bowel, making the procedure more similar to EUS-guided drainage of pancreatic fluid with a LAMS. The EPASS balloon device, however, is not available outside of select Asian centers.

Our study is the first outside of Asia to describe an experience with an occlusive double-balloon device for EUS-GE. Our M-EPASS approach uses repurposed vascular balloon catheters that are easily accessible throughout the world. Our data demonstrate excellent technical and clinical success, with very low risk of stent dysfunction outside of food impaction from non-compliance with the low residue diet.

Technically, the device greatly facilitated EUS-guided cautery-assisted LAMS insertion. Our early results suggest that M-EPASS is possible with the patient under EDCS, but that general anesthesia support is likely the preferred sedation modality. In terms of adverse events, we did not observe any stent misdeployment. The only severe adverse event was an unusual case of stent migration, likely due to the inadvertent insertion of the stent through the mesentery prior to entry into the small bowel. We postulate that the small bowel pulled away from the stent as the patient stood up and the mesentery descended with gravity. In this case, although the distance between the stomach and small bowel measured less than 7 mm on EUS, this space was occupied by intensely hyperechoic tissue, which in hindsight likely represented small-bowel mesentery.

In terms of the limitations of the technique, the advancement of the catheter across the stomach can be challenging, which explains the relatively long procedure time. An improvement in the “pushability” of the device will be a key component in facilitating this approach. However, once the double-balloon device is in position, EUS-GE is quite easily performed, which should make this technique relatively easy to adopt overall. Although the direct water-infusion technique has been shown to be safe in expert hands [2], this approach has not led to widespread adoption, given its unforgiving nature. Whether the use of a double device truly makes EUS-GE safer remains to be confirmed. In addition, only the 15-mm LAMS was used in our study, as the 20-mm LAMS was not available at our center during the study period; however, it is unclear whether a 20-mm LAMS is necessary, given the excellent clinical success reported in both our study and others that have also used the smaller stent [1] [2] [3]. The general limitations of our study include its small sample size, as well as its retrospective and single-center design, which limit its validity and generalizability.

In conclusion, the M-EPASS method uses widely available technology to facilitate EUS-GE. In this single-center study, it demonstrated promising results. Improvements to associated devices and randomized controlled data are both urgently needed in order for EUS-GE to move beyond the developmental phase and become a practice-changing modality.

Competing interests

Yen-I Chen is a consultant for Boston Scientific. Nauzer Forbes is a consultant for Boston Scientific and Pentax Medical and has received personal funds from Boston Scientific and Pentax Medical. Mouen Khashab is a consultant for Boston Scientific, Medtronic, and Olympus. The remaining authors declare that they have no conflict of interest.

• References

• 1 Chen YI, Itoi T, Baron TH. et al. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc 2017; 31: 2946-2952
  CrossrefPubMedSearch in Google Scholar
• 2 Chen YI, Kunda R, Storm AC. et al. EUS-guided gastroenterostomy: a multicenter study comparing the direct and balloon-assisted techniques. Gastrointest Endosc 2018; 87: 1215-1221
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• 3 Kastelijn JB, Moons LMG, Garcia-Alonso FJ. et al. Patency of endoscopic ultrasound-guided gastroenterostomy in the treatment of malignant gastric outlet obstruction. Endosc Int Open 2020; 8: E1194-E1201
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• 4 Chen YI, Khashab MA. Endoscopic approach to gastrointestinal bypass in malignant gastric outlet obstruction. Curr Opin Gastroenterol 2016; 32: 365-373
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• 5 Miller CS, Chen YI, Haito Chavez Y. et al. Double-balloon endoscopic ultrasound-guided gastroenterostomy: simplifying a complex technique towards widespread use. Endoscopy 2020; 52: 151-152
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• 6 Itoi T, Ishii K, Ikeuchi N. et al. Prospective evaluation of endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for malignant gastric outlet obstruction. Gut 2016; 65: 193-195
  CrossrefPubMedSearch in Google Scholar
• 7 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
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• 8 Barkun JS, Aronson JK, Feldman LS. et al. Evaluation and stages of surgical innovations. Lancet 2009; 374: 1089-1096
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• 9 Chen YI, Yang J, Friedland S. et al. Lumen apposing metal stents are superior to plastic stents in pancreatic walled-off necrosis: a large international multicenter study. Endosc Int Open 2019; 7: E347-E354
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Corresponding author

Publication History

Received: 26 November 2020

Accepted: 16 February 2021

Accepted Manuscript online:
16 February 2021

Article published online:
20 April 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

• References

• 1 Chen YI, Itoi T, Baron TH. et al. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc 2017; 31: 2946-2952
  CrossrefPubMedSearch in Google Scholar
• 2 Chen YI, Kunda R, Storm AC. et al. EUS-guided gastroenterostomy: a multicenter study comparing the direct and balloon-assisted techniques. Gastrointest Endosc 2018; 87: 1215-1221
  CrossrefPubMedSearch in Google Scholar
• 3 Kastelijn JB, Moons LMG, Garcia-Alonso FJ. et al. Patency of endoscopic ultrasound-guided gastroenterostomy in the treatment of malignant gastric outlet obstruction. Endosc Int Open 2020; 8: E1194-E1201
  Thieme ConnectPubMedSearch in Google Scholar
• 4 Chen YI, Khashab MA. Endoscopic approach to gastrointestinal bypass in malignant gastric outlet obstruction. Curr Opin Gastroenterol 2016; 32: 365-373
  CrossrefPubMedSearch in Google Scholar
• 5 Miller CS, Chen YI, Haito Chavez Y. et al. Double-balloon endoscopic ultrasound-guided gastroenterostomy: simplifying a complex technique towards widespread use. Endoscopy 2020; 52: 151-152
  Thieme ConnectPubMedSearch in Google Scholar
• 6 Itoi T, Ishii K, Ikeuchi N. et al. Prospective evaluation of endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for malignant gastric outlet obstruction. Gut 2016; 65: 193-195
  CrossrefPubMedSearch in Google Scholar
• 7 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
  CrossrefPubMedSearch in Google Scholar
• 8 Barkun JS, Aronson JK, Feldman LS. et al. Evaluation and stages of surgical innovations. Lancet 2009; 374: 1089-1096
  CrossrefPubMedSearch in Google Scholar
• 9 Chen YI, Yang J, Friedland S. et al. Lumen apposing metal stents are superior to plastic stents in pancreatic walled-off necrosis: a large international multicenter study. Endosc Int Open 2019; 7: E347-E354
  Thieme ConnectPubMedSearch in Google Scholar

• Supplementary Material