Introduction

Gastric outlet obstruction is a common manifestation of advanced gastric, duodenal, and periampullary malignancies, severely affecting quality of life. Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) may be superior to surgical gastroenterostomy (SGJ) as palliative treatment for this condition, but randomised trials are currently lacking.

Aims & Methods

We performed a multicenter, randomized controlled trial involving palliative patients with a malignant obstruction localized between the pylorus and the distal duodenum, randomizing them 1:1 to either EUS-GE or SGJ. The first co-primary superiority end point was time to solid oral intake. The second co-primary non-inferiority end point was persistent or recurrent obstructive symptoms for which a reintervention was required within six months after treatment. The predefined non-inferiority margin was 20%.

Results

From February 2022 to February 2024, 250 patients were screened in 12 participating hospitals in the Netherlands. Of the 98 enrolled patients, 48 were assigned to EUS-GE and 50 were assigned to SGJ. Median age was 69 versus 70 years and the most prevalent etiology was pancreatic cancer in 58% versus 50% in the EUS-GE group and SGJ group, respectively. Median time to oral intake was significantly shorter in the EUS-GE group compared to the SGJ group: 1 day versus 3 days (hazard ratio, 2.21, 95% CI, 1.43 to 3.42, p=0.0003). In the endoscopic group, 5 patients (10%) experienced persistent or recurrent obstructive symptoms requiring reintervention, compared with 6 patients (12%) in the surgical group (risk difference, 1.6%, upper limit of 90% CI, 8.9%). Clinical success, defined as the ability to tolerate solid oral intake, was higher in the EUS-GE group (96% versus 80%, relative risk, 1.20, 95% CI, 1.03 to 1.39). Median length of hospital stay was shorter in the EUS-GE group (1 day versus 4 days, relative change, 0.46, 95% CI, 0.20 to 0.78). Serious adverse events, defined as Clavien-Dindo ≥3B, were observed in 8% of patients in the EUS-GE group and in 12% of patients in the SGJ group (relative risk, 0.69, 95% CI, 0.21 to 2.31). Median survival was 91 days after EUS-GE (95% CI, 74 to 140) and 74 days (95% CI, 46 to 110) after SGJ. Thirty-day mortality was 13% in the EUS-GE group and 26% in the SGJ group (relative risk, 0.48, 95% CI, 0.20 to 1.14). In the first three months following the procedure, quality of life was not different between the two treatments.

Conclusion

This trial showed that EUS-GE, compared to SGJ, is superior in terms of time to solid oral intake and non-inferior with regards to the rate of persistent or recurrent obstructive symptoms requiring reintervention. Based on these results, EUS-GE should be the preferred palliative treatment for malignant gastric outlet obstruction.

Disclosure

Yorick L. van de Pavert, Janine B. Kastelijn, Marc G. Besselink, Dieke C. Booij, Jurjen J. Boonstra, Judith Boot, Olivier R.C. Busch, Wouter J.M. Derksen, Bas Groot Koerkamp, Akin Inderson, Wim J. Lammers, Daan J. Lips, J. Sven D. Mieog, I. Quintus Molenaar, Alexander A.F.A. Veenhof, Niels G. Venneman, Robert C. Verdonk, Paco M.J. Welsing, Thomas R. de Wijkerslooth, and Hjalmar C. van Santvoort report no conflicts of interest.
Freek Daams is proctor for Intuitive, received educational grants from Medtronic, and received speaker’s fees from Johnson & Johnson and Medtronic.
Paul Fockens is consultant for Cook Endoscopy and Olympus.
Rogier P. Voermans reports research grants from Boston Scientific and Prion Medical, performed as a consultant for Boston Scientific and Cook Medical, and received speaker’s fees from Mylan and Zambon.
Roy L.J. van Wanrooij is a consultant for Boston Scientific.
Marco J. Bruno is a consultant for Boston Scientific, Cook Medical, and Pentax Medical; received support for industry-initiated studies from Boston Scientific and Cook Medical; and received support for investigator-initiated studies from Boston Scientific, Cook Medical, Pentax Medical, Mylan, Interscope, and ChiRhoStim.
Jeanin E. van Hooft received lecture fees from Cook Medical, Boston Scientific, Medtronic, and Abbvie, is an independent observer for Olympus, and is the current secretary general of the federation United European Gastroenterology (UEG).
Leon M.G. Moons is a consultant for Boston Scientific.
Frank P. Vleggaar is a consultant for Boston Scientific.

Introduction

Post-procedural pancreatitis (PPP) is the most common adverse event associated with endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent is emerging as a promising approach for managing malignant distal biliary obstruction (MDBO), offering the potential to lower the risk of PPP. We compared the outcomes of EUS-CDS with ERCP when used as the primary modality for biliary decompression.

Aims & Methods

This was a multicenter randomized controlled study, enrolling consecutive patients admitted for obstructive jaundice due to malignant distal biliary obstruction with dilated common bile duct (CBD>15mm). Patients were randomly allocated to receive EUS-CDS or ERCP for primary biliary drainage. This was a superiority trial with post-procedural acute pancreatitis (abdominal pain, elevation in pancreatic enzymes, and hospitalisation) as primary outcome. Other outcomes included technical success, clinical success, adverse events, 6-months stent patency rate, and overall survival. Analyses were performed according to intention-totreat principles.

Results

Between April 2021 and October 2023, 220 patients were enrolled in the study (EUS-CDS group: 111; ERCP group: 109). EUS-CDS group showed a lower risk for post-procedural acute pancreatitis (1.8% in EUS-CDS group vs 7.3% in ERCP group; RR: 0.25, 95%CI 0.07-0.88). Technical success was achieved in 94.6% in EUS-CDS group vs 78.9% ERCP group (p value: <0.001), in a mean procedural time of 13.5+11.6 minutes, and 24.7+14.9 minutes, respectively (p value: <0.001). No differences were found in other adverse events, clinical success, stent patency, or overall mortality

Conclusion

EUS-CDS is superior to ERCP in reducing post-procedural acute pancreatitis risk, without significantly affecting the overall risk of adverse events. Additionally EUS-CDS showed improved technical success, and comparable clinical efficacy. These results support the use of EUS-CDS as the potential preferred primary approach in patients with dilated CBD (NCT04099862).