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ECDS Proves Mettle for Drainage in Distal Biliary Obstruction

— Clinical outcomes mirror gold standard approach; stent patency may be superior

Last Updated May 24, 2021
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Endoscopic ultrasound-guided choledochoduodenostomy (ECDS) proved technically better than endoscopic retrograde cholangiopancreatography (ERCP) for bile drainage in patients with tumor-related distal biliary obstruction, a researcher reported.

In a study of more than 100 patients with common bile duct strictures at a dozen institutions, ECDS was associated with a significantly higher technical success rate than ERCP of 93.7% versus 77.2%, and was faster than ERCP, with an average procedure time of 15 minutes versus 28.6 minutes, according to Anthony Y.B. Teoh, MD, of the Chinese University of Hong Kong.

Several patients in the ERCP arm failed treatment because of duodenal obstruction or cannulation failure due to a very tight tumor. But there was was no difference in 30-day clinical success, hospital stays, adverse events, and mortality or stent dysfunction rates, he reported at the Digestive Disease Week (DDW) virtual meeting.

Although 1-year data on outcomes and stent patency are still pending, ECDS may be a time-saving option, Teoh stated. His group also hypothesized that stent patency would be better in the ECDS than the conventional ERCP arm as the stent is placed away from the tumor and may forestall tumor ingrowth.

Malignant distal biliary obstruction is most frequently caused by pancreatic cancer with biliary obstruction as the first presentation of the cancer,and often at an advanced stage. Consequently, the majority of patients with malignant distal biliary obstruction are unresectable, meaning treatment and bile drainage require more than removal of the tumor.

The study arms compared these two duct drainage techniques in patients with unresectable malignant distal common bile duct strictures:

  • ECDS with enhanced lumen apposing stents
  • ERCP with covered metallic stents

The primary outcome was 1-year stent potency according to radiologically and endoscopically assessed obstruction. Secondary outcomes were technical sussess, adverse events (AEs), re-intervention rates, and mortality.

During January 2017 to November 2020, the study recruited 160 patients with common bile duct strictures from 12 institutions. Those with a bile duct size of <12 mm, or a distance of >1 cm between the duct and duodenum, were excluded, as were two patients in the ERCP arm because of protocol violations. In the event of a failure of intervention, affected patients were allowed to cross over to the other arm.

No significant differences were observed in hospital stays (6 vs 4.5 days, P=0.272), 30-day AE rates (19.2% vs 17.6%, P=0.812), 30-day mortality rates (5.1% vs 6.5%, P=0.744), and 1-year stent dysfunction rates (8.9% vs 8.9%).

The authors reported that the causes of stent dysfunction differed in the two arms. In the ERCP group, six patients had tumor ingrowth, while in one, food residue interfered with the stent. In ECDS patients, causes included a partially migrated infection, tumor ingrowth, food impaction, and impingement of the stent on the opposite wall of the common bile duct.

Tumor ingrowth seemed to occur less frequently in the ECDS arm, they noted.

ECDS "may have some advantage, particularly in the short term, and should be considered an option for primary drainage in patients with duodenal obstruction," Teoh said. He recommended practicing thorough surveillance of endoscope channels to minimize minimize endoscope-related infections.

DDW session moderator Bret T. Petersen, MD, of the Mayo Clinic in Rochester, Minnesota, said the study provides supportive guidance for practitioners of both approaches, given the equivalent results when the duodenum can be traversed and the papilla reached. He added that transduodenal drainage should be the preferred approach in those who fail ERCP.

Given that tumor ingrowth was the primary mechanism of failure in papillary stenting, he asked whether fully covered stents might reduce that outcome. "The next question will be the relative benefit and safety of intraduodenal or intragastric drainage coupled with enteral stenting of the duodenum versus endoscopic jejunostomy. We look forward to the longer-term results of this study," Petersen said.

  • author['full_name']

    Diana Swift is a freelance medical journalist based in Toronto.

Disclosures

Teoh disclosed relevant relationships with Boston Scientific, Cook Medical, Microtech Medical, and Taewoong Medical.

Primary Source

Digestive Diseases Week

Teoh AYB, et ao "EUS-guided choledochoduodenostomy versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction. A multi-centered randomized controlled trial (DRA-MBO Trial)" DDW 2021; Abstract 335.