New Approach Reduces Mortality, Complications in Malignant Biliary Obstruction

Patients with malignant biliary obstruction (MBO) who underwent endoscopic retrograde cholangiopancreatography (ERCP) with stent placement combined with radiofrequency ablation (RFA) experienced significantly lower six-month mortality, along with reduced rates of post-ERCP pancreatitis and cholangitis, compared to those treated with stenting alone. These findings, presented at the recent Digestive Disease Week Annual Meeting, suggest that RFA may enhance clinical outcomes and improve biliary drainage when used alongside standard stent placement.

“We aim to provide effective treatment options for patients with complex pancreatic and bile duct cancers—two of the leading causes of biliary strictures, or narrowing of the bile duct,” says study author Hassan Siddiki, MD, of the Department of Gastroenterology, Hepatology & Nutrition at Cleveland Clinic. “To relieve the obstruction, we typically place stents—small plastic or metal tubes designed to keep the bile duct open.”

However, stents alone have limitations. “They can malfunction by becoming clogged, obstructed by debris or tumor ingrowth, migrating, or even causing bleeding,” Dr. Siddiki explains. “When this happens, patients often need to return for replacement procedures, which can significantly impact their quality of life.”

To address these challenges, the Cleveland Clinic team explored the use of RFA, a thermal therapy that uses heat to treat tissue. “It’s already used in other areas of the gastrointestinal tract, like the esophagus,” notes Dr. Siddiki. “Our approach was to apply RFA directly to the tumor within the bile duct before placing the stent, with the goal of prolonging stent function and reducing the likelihood of malfunction and the need for repeated procedures.”

Study design

Through this retrospective cohort analysis, Dr. Siddiki and colleagues compared survival, efficacy, and the incidence of adverse outcomes between ERCP with stent only versus ERCP with stent and radiofrequency ablation.

“We hypothesized that patients undergoing RFA before stent placement would experience longer intervals without stent dysfunction, ultimately leading to better quality of life,” notes Dr. Siddiki. “To test this, we analyzed outcomes between patients treated with stenting alone and those who received both RFA and stenting, using a large, real-world dataset.”

Data were sourced from the TriNetX Global Collaborative Network, which includes de-identified electronic health records from 134 healthcare organizations. The study population was comprised of patients diagnosed with MBO who underwent ERCP with stent placement only (n = 94,367) and those who received ERCP with both stent placement and RFA (n = 2,265) over five years.

To minimize confounding, propensity score matching was applied to balance baseline demographics and comorbidities, resulting in two matched cohorts of 1,902 patients each, according to the study authors. The primary outcome was six-month all-cause mortality. Secondary outcomes included post-ERCP pancreatitis, cholangitis, and recurrent jaundice requiring repeat intervention.

Findings and next steps

The study demonstrated that combining radiofrequency ablation with stent placement during endoscopic retrograde cholangiopancreatography significantly improves clinical outcomes in patients with malignant biliary obstruction, when compared to stenting alone.

Patients in the ERCP with stent-only cohort experienced higher rates of complications across multiple metrics. In contrast, those in the ERCP with stent and RFA cohort had:

• Lower six-month mortality (OR: 1.29, 95% CI: 1.08–1.54, p = 0.005).
• Reduced incidence of post-ERCP pancreatitis (OR: 1.40, 95% CI: 1.05–1.88, p = 0.022)
• Lower rates of cholangitis (OR: 1.59, 95% CI: 1.24–2.04, p < 0.001)
• Decreased risk of jaundice recurrence (OR: 1.87, 95% CI: 1.41–2.49, p < 0.001)

“These findings confirmed our hypothesis,” says Dr. Siddiki. “Combining RFA with stenting was clearly more effective than stenting alone. For patients with cancer-related biliary strictures, we recommend—when it can be safely performed—that RFA be incorporated into routine stent placement.”

These results are already shaping clinical practice at Cleveland Clinic. According to Dr. Siddiki, RFA is now being considered as a routine component of stent procedures for eligible patients, depending on factors such as the size, location, and severity of the stricture.

Moving forward, the team plans to explore the potential benefits of RFA in benign, non-cancer-related biliary strictures. Non-malignant causes such as bile duct stones, surgical anastomoses, and chronic pancreatitis can also result in strictures, and the researchers believe that RFA may improve outcomes in these cases as well.

“We’re always looking for ways to help our patients live healthier, better-quality lives—especially those with challenging diagnoses like pancreatic cancer. We want them to be able to spend more time with their families and focus on their overall care,” concludes Dr. Siddiki. “Using technologies like RFA to reduce hospital visits is one of the many ways we’re working to support that goal.”

DDW Abstract: “Stent Placement with Radiofrequency Ablation (RFA) is Superior to Stent Alone for Malignant Biliary Strictures: Outcomes in 3,804 Propensity Score Matched Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)”