Radiofrequency Ablation for Malignant Biliary Obstruction

NCT01758341 | Completed Phase 4

• 1 other identifier: EK 1837/2012
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Biliary obstruction is importantly influencing quality of life and survival of patients suffering from primary or secondary bile duct malignancies. The aim of this retrospective data analysis is to evaluate endoscopic radiofrequency ablation (RFA) with the HabibTM EndoHBP catheter for the treatment of malignant biliary obstruction. RFA procedures performed in Austria so far will be analyzed with regard to feasibility and safety of the technique. Therefore, the following parameters will be assessed: (among others) technical failures during the RFA procedure, complications during the RFA procedure, hospital stay, adverse events during hospital stay and until first clinical control after discharge (an expected average of 4 weeks after RFA procedure), 30-day and 90-day mortality. The results of this study should help to better understand important aspects of biliary RFA which may positively influence future applications of this method.

Conditions

Biliary Tract Neoplasms

Keywords

Malignant biliary obstruction; Endoscopic radiofrequency ablation; Therapeutic endoscopy

Outcome Measures

Primary Outcomes (1)

• Number of RFA-procedures with technical failures

  The technical feasibility in this study will be specified as ratio of all technically successful RFA-applications to all examinations in which RFA-use was intended. A RFA-application will be classified as technically successful if it is possible to introduce the RFA-catheter into the biliary system, place it adequately accross the malignant stricture, apply RFA-energy and withdraw the RFA-catheter after RFA-application.

  During the respective RFA-examination (an expected average of 1 hour)

Secondary Outcomes (1)

• Number of patients with interventional complications

  During the respective RFA-procedure (an expected average of 1 hour)

Other Outcomes (3)

• Hospital stay

  Inpatient stay after RFA-procedure (an expected average of 5 days)

• Number of patients with Adverse events as a Measure of Safety and Tolerability

  During hospital stay and until first clinical control after discharge (an expected average of 4 weeks after RFA procedure)

• Mortality

  30 days and 90 days after RFA-procedure (calculating 30- and 90-day mortality rate), assessed retrospectively by screening clinical reports (including death reports) of the study patients on average 1 year after RFA-procedure

Study Arms (1)

Malignant biliary obstruction

EXPERIMENTAL

All patients who underwent endoscopic radiofrequency ablation with the HabibTM EndoHBP as a treatment for malignant biliary obstruction in Austria between November 2010 and December 2012.

Procedure: Endoscopic radiofrequency ablation; Procedure: Endoscopic retrograde cholangiopancreatography (ERCP); Device: HabibTM EndoHPB catheter

Interventions

Endoscopic radiofrequency ablation PROCEDURE

Endoscopic radiofrequency ablation with the HabibTM EndoHBP catheter uses bipolar electrical energy for tissue coagulation and can be applied without any special patient preparation in the context of an endoscopic retrograde cholangiopancreatography (ERCP) examination to treat malignant biliary strictures.

Malignant biliary obstruction

Endoscopic retrograde cholangiopancreatography (ERCP) PROCEDURE

ERCP is used to guide the RFA-catheter under radiological control to the location of the malignant stricture.

Malignant biliary obstruction

HabibTM EndoHPB catheter DEVICE

Used to apply radiofrequency energy to the malignant biliary stricture (see also intervention "endoscopic radiofrequency ablation")

Malignant biliary obstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

All patients who underwent endoscopic radiofrequency ablation with the HabibTM EndoHBP as a treatment for malignant biliary obstruction in Austria between November 2010 and December 2012.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology

Vienna, Austria

Location

Related Publications (10)

• de Groen PC, Gores GJ, LaRusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med. 1999 Oct 28;341(18):1368-78. doi: 10.1056/NEJM199910283411807. No abstract available.

  PMID: 10536130 BACKGROUND

• Skipworth JR, Olde Damink SW, Imber C, Bridgewater J, Pereira SP, Malago M. Review article: surgical, neo-adjuvant and adjuvant management strategies in biliary tract cancer. Aliment Pharmacol Ther. 2011 Nov;34(9):1063-78. doi: 10.1111/j.1365-2036.2011.04851.x. Epub 2011 Sep 20.

  PMID: 21933219 BACKGROUND

• Smith AC, Dowsett JF, Russell RC, Hatfield AR, Cotton PB. Randomised trial of endoscopic stenting versus surgical bypass in malignant low bileduct obstruction. Lancet. 1994 Dec 17;344(8938):1655-60. doi: 10.1016/s0140-6736(94)90455-3.

  PMID: 7996958 BACKGROUND

• Kaassis M, Boyer J, Dumas R, Ponchon T, Coumaros D, Delcenserie R, Canard JM, Fritsch J, Rey JF, Burtin P. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc. 2003 Feb;57(2):178-82. doi: 10.1067/mge.2003.66.

  PMID: 12556780 BACKGROUND

• Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc. 2006 Jun;63(7):986-95. doi: 10.1016/j.gie.2005.11.052.

  PMID: 16733114 BACKGROUND

• Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mossner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003 Nov;125(5):1355-63. doi: 10.1016/j.gastro.2003.07.015.

  PMID: 14598251 BACKGROUND

• Zoepf T, Jakobs R, Arnold JC, Apel D, Riemann JF. Palliation of nonresectable bile duct cancer: improved survival after photodynamic therapy. Am J Gastroenterol. 2005 Nov;100(11):2426-30. doi: 10.1111/j.1572-0241.2005.00318.x.

  PMID: 16279895 BACKGROUND

• Minami Y, Kudo M. Radiofrequency ablation of hepatocellular carcinoma: Current status. World J Radiol. 2010 Nov 28;2(11):417-24. doi: 10.4329/wjr.v2.i11.417.

  PMID: 21179308 BACKGROUND

• Itoi T, Isayama H, Sofuni A, Itokawa F, Tamura M, Watanabe Y, Moriyasu F, Kahaleh M, Habib N, Nagao T, Yokoyama T, Kasuya K, Kawakami H. Evaluation of effects of a novel endoscopically applied radiofrequency ablation biliary catheter using an ex-vivo pig liver. J Hepatobiliary Pancreat Sci. 2012 Sep;19(5):543-7. doi: 10.1007/s00534-011-0465-7.

  PMID: 22038500 BACKGROUND

• Steel AW, Postgate AJ, Khorsandi S, Nicholls J, Jiao L, Vlavianos P, Habib N, Westaby D. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc. 2011 Jan;73(1):149-53. doi: 10.1016/j.gie.2010.09.031.

  PMID: 21184881 BACKGROUND

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Werner Dolak, MD

  Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: January 1, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

AU (1)