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P20 First report of the long-term efficacy of a novel endoscopic radiofrequency ablation technique for malignant biliary obstruction
  1. Y Kallis1,
  2. N Phillips1,
  3. A Steel2,
  4. C Baldwin3,
  5. J Nicholls4,
  6. L Jiao4,
  7. P Vlavianos1,
  8. N Habib4,
  9. D Westaby1
  1. 1Department of Gastroenterology, Imperial College Healthcare, London
  2. 2Department of Gastroenterology, Chelsea and Westminster Hospital, London
  3. 3Faculty of Medicine, Imperial College, London
  4. 4Academic Department of Surgery, Hammersmith Hospital, Imperial College, London

Abstract

Introduction Insertion of self-expanding metal stents (SEMS) is standard practice in patients with unresectable malignant biliary strictures. Stent occlusion is a significant clinical problem in patients surviving beyond 3 months. A pioneering phase I/II study in our tertiary referral centre demonstrated good safety and 30-day patency using a novel endoscopic radiofrequency ablation (RFA) technique as an adjunct to SEMS.1 The longer term impact of combined RFA+SEMS on biliary drainage and overall patient survival is unknown.

Aim To investigate long-term safety and efficacy of endobiliary RFA in malignant bile duct obstruction.

Method Retrospective cohort analysis of 24 patients undergoing RFA+SEMS (17 pancreatic carcinoma; 7 cholangiocarcinoma) and 44 matched controls undergoing SEMS insertion alone (34 pancreatic carcinoma, 10 cholangiocarcinoma) for malignant biliary obstruction in a single tertiary referral centre. Patients were matched for age, sex, disease, presence of metastases, ASA/co-morbidities, and intention to treat with palliative chemotherapy. Patients with a potential minimum of 6-month follow-up were included and survival, maintenance of stent patency and procedure-related complications were assessed.

Results RFA treated and control cohorts were closely matched- mean age 71.8±9.8 yrs vs 68.8±10.3, metastases at treatment 9/24 (38%) vs 17/44 (39%), chemotherapy 16/24 (67%) vs 27/44 (61%). Kaplan–Meier analysis showed a median survival of 227 days in the RFA group vs 159 days in controls (p=0.067). Multivariate analysis showed RFA treatment to be the strongest predictor of survival at 90 days (OR 26.1, p=0.011). Survival benefits may extend beyond 90 days (OR 2.8, p=0.071 at 180 days; OR 2.8, p=0.102 at 360 days), but require further investigation. Within 6 months after treatment, more patients were alive with a patent first SEMS in the RFA cohort than in controls. Complications of RFA were few (1 pancreatitis, 2 cholecystitis) and comparable to those associated with standard ERCP alone. The procedure was well-tolerated with a median post-procedure inpatient stay of 1 day (1–24).

Conclusion In the single largest case series studied to date, endobiliary RFA is a safe and efficacious treatment for malignant biliary obstruction, with potential early survival benefit. Large multi-centre prospective trials of this novel treatment modality are warranted.

Abstract P20 Figure 1

Kaplan–Meier survival analysis.

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