Innovative Protocol for Common Bile Duct Stone Clearance Published in Digestive Endoscopy

Research on a new protocol developed by internationally respected specialists at the Orlando Health Digestive Health Institute was recently published in Digestive Endoscopy. The open access paper, entitled Orlando Protocol for single session ductal clearance of common bile duct stones at endoscopic retrograde cholangiopancreatography, concluded that a predetermined protocol optimized outcomes by enabling single-session ductal clearance of CBDS with high technical success and low adverse events.

Endoscopic retrograde cholangiopancreatography (ERCP) with biliary sphincterotomy and stone extraction is accepted procedural treatment for common bile duct stones (CBDS). However, extraction by standard methodology does not work for more difficult cases.

“There has been no standardized approach to managing common bile duct stones by endoscopic retrograde cholangiopancreatography, despite not-infrequent technical challenges,” says Shyam S. Varadarajulu, MD, president of Orlando Health Digestive Health Institute. “Our proposed ‘Orlando’ protocol provides a framework whereby the underlying challenge is clearly defined and then objectively managed.”

The study analyzed 409 patients treated from February 2022 to May 2023. A management protocol taking into consideration stone size and bile duct diameter was applied prospectively on consecutive patients with CBDS aged ≥18 years who underwent ERCP. All procedures were performed by four therapeutic endoscopists with Orlando Health Digestive Health Institute. By adopting a protocol-based treatment approach, single-session ductal clearance was achieved in more than 99 percent of patients with severe to mild adverse events occurring in less than 5 percent.

“Our research concluded the ‘Orlando’ protocol enables efficient single session ductal clearance of CBDS with high rate of technical success and low adverse events,” says Dr. Varadarajulu. “If adopted, we believe this protocol could offer improved clinical outcomes and yield cost savings.”

Principal investigators of the study published in Digestive Endoscopy include physicians Ji Young Bang, MD; C. Mel Wilcox, MD; Udayakumar Navaneethan, MD; Robert Hawes, MD; and Dr. Varadarajulu.

A referral center of excellence, Orlando Health Digestive Health Institute provides comprehensive and coordinated care to evaluate, diagnose and treat a multitude of digestive diseases. The institute’s internationally respected specialists are frequent contributors to leading publications on gastroenterology and endoscopy, and spearhead numerous research and educational initiatives globally.