RFA for Malignant Biliary Obstruction

RFA for Malignant Biliary Obstruction

Currently Recruiting.

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Purpose
Pancreatic cancer and cholangiocarcinoma are the most common causes of malignant biliary obstruction. They are diseases of increasing incidence and unfavorable prognosis. Only a minority of patients have a localized disease and are indicated for surgery with a chance of long-term survival. Locally advanced and metastatic tumors are treated with palliative chemotherapy or chemoradiotherapy; the results of such treatments are unsatisfactory. The average survival of patients with unresectable disease is 6 months and only 5 – 10 % of patients survive 5 years. Chemotherapy and radiotherapy can be used, however only with a palliative effect. Biliary drainage is an integral part of palliative treatment. Endoscopically or percutaneously placed stents improve quality of life, decrease cholestasis and pruritus, but do not significantly improve survival. Biliary stents get occluded over time, possibly resulting in acute cholangitis and require repeated replacement. Endoluminal biliary photodynamic therapy (PDT) and radiofrequency ablation (RFA), locally active endoscopic methods, have been increasingly used in recent years in palliative treatment of patients with malignant biliary obstruction. In photodynamic therapy, improved survival has been shown in two randomized controlled trials; however the technique suffers from technical complexity, high cost and low availability. In RFA, application of low voltage high frequency current during radiofrequency ablation results in tissue destruction by heat. Its antitumor effect may also be related to systemic changes in antitumor immunity. The use of endoluminal biliary RFA has so far been reported only in small retrospective cohorts of patients.

The aim of this randomized study is to compare efficacy of RFA plus stenting to stenting alone in palliative treatment of malignant biliary obstruction with survival as primary outcome. Secondary outcomes are stent patency, immediate and late complications, quality of life and effects on anti-tumor immunity in the RFA group.

Condition Intervention
Cholangiocarcinoma
Pancreas Cancer
Procedure: Radiofrequency ablation
Procedure: Biliary stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled study
Masking: No masking
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation Plus Stenting Versus Stenting Alone for Treatment of Malignant Biliary Obstruction

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma
U.S. FDA Resources

Further study details as provided by Institute for Clinical and Experimental Medicine:

Primary Outcome Measures:
Survival [ Time Frame: 12 months ]
number of days/months of survival (being alive) post intervention

Secondary Outcome Measures:
Stent patency [ Time Frame: 12 months ]
number of days/months of patent stent (not occluded) post intervention

Complications [ Time Frame: 30 days ]
number of complications related to procedure (bleeding, perforation, cholangitis will be combined to report as a complication)

Quality of life [ Time Frame: 12 months ]
validated questionnaire investigating quality of live post intervention

Augmentation of antitumor immunity [ Time Frame: 30 days ]
serum level of HSP 70 and selected cytokines will be measured from blood

Estimated Enrollment: 140
Anticipated Study Start Date: June 8, 2017
Estimated Study Completion Date: May 8, 2020
Estimated Primary Completion Date: May 8, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RFA plus stenting
Endoluminal radiofrequency ablation followed by biliary stenting
Procedure: Radiofrequency ablation
Endoluminal radiofrequency ablation using a ERC-based catheter
Procedure: Biliary stenting
Placing a metal or plastic stent in the bile duct
Active Comparator: Stenting alone
Biliary stenting alone
Procedure: Biliary stenting
Placing a metal or plastic stent in the bile duct

Show Detailed Description

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Age over 18
Pathologically confirmed malignant bile duct obstruction (cholangiocarcinoma or pancreatic cancer)
Laboratory signs of biliary obstruction
Non-resectable disease (distant metastasis, locally advanced disease, patient related factors) based on a multidisciplinary team decision
Capability of giving informed consent
Life expectancy greater than 3 months
Exclusion Criteria:

Unstable for ERC
Inability to give informed consent
Pregnancy
Uncorrected coagulopathy
Concomitant biliary oncological endoluminal therapy (photodynamic therapy, brachytherapy)
Cardiac pacemaker
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03166436

Contacts
Contact: Tomas Hucl, MD, PhD 00420261362600 tomas.hucl@ikem.cz
Contact: Petra Truxova, Ing 00420261362619 petra.truxova@ikem.cz

Locations
Czechia
Department of Gastroenterology and Hepatology Recruiting
Prague, Czechia, 14021
Contact: Tomas Hucl, MD, PhD 00420261362600 tomas.hucl@ikem.cz
Contact: Petra Truxova, Ing 00420261362619 petra.truxova@ikem.cz
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Investigators
Principal Investigator: Tomas Hucl, MD, PhD IKEM
More Information

Publications:
Rizvi S, Gores GJ. Pathogenesis, diagnosis, and management of cholangiocarcinoma. Gastroenterology. 2013 Dec;145(6):1215-29. doi: 10.1053/j.gastro.2013.10.013. Epub 2013 Oct 15. Review.
Khan SA, Davidson BR, Goldin RD, Heaton N, Karani J, Pereira SP, Rosenberg WM, Tait P, Taylor-Robinson SD, Thillainayagam AV, Thomas HC, Wasan H; British Society of Gastroenterology.. Guidelines for the diagnosis and treatment of cholangiocarcinoma: an update. Gut. 2012 Dec;61(12):1657-69. doi: 10.1136/gutjnl-2011-301748. Epub 2012 Aug 15.
Rerknimitr R, Angsuwatcharakon P, Ratanachu-ek T, Khor CJ, Ponnudurai R, Moon JH, Seo DW, Pantongrag-Brown L, Sangchan A, Pisespongsa P, Akaraviputh T, Reddy ND, Maydeo A, Itoi T, Pausawasdi N, Punamiya S, Attasaranya S, Devereaux B, Ramchandani M, Goh KL; Asia-Pacific Working Group on Hepatobiliary Cancers.. Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma. J Gastroenterol Hepatol. 2013 Apr;28(4):593-607. doi: 10.1111/jgh.12128. Review.
Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. Lancet. 2011 Aug 13;378(9791):607-20. doi: 10.1016/S0140-6736(10)62307-0. Epub 2011 May 26. Review.
Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992 Dec 19-26;340(8834-8835):1488-92.
Sangchan A, Kongkasame W, Pugkhem A, Jenwitheesuk K, Mairiang P. Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial. Gastrointest Endosc. 2012 Jul;76(1):93-9. doi: 10.1016/j.gie.2012.02.048. Epub 2012 May 15.
Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mössner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003 Nov;125(5):1355-63.
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.
Curley SA, Izzo F. Radiofrequency ablation of primary and metastatic hepatic malignancies. Int J Clin Oncol. 2002 Apr;7(2):72-81. Review.
Shaheen NJ, Overholt BF, Sampliner RE, Wolfsen HC, Wang KK, Fleischer DE, Sharma VK, Eisen GM, Fennerty MB, Hunter JG, Bronner MP, Goldblum JR, Bennett AE, Mashimo H, Rothstein RI, Gordon SR, Edmundowicz SA, Madanick RD, Peery AF, Muthusamy VR, Chang KJ, Kimmey MB, Spechler SJ, Siddiqui AA, Souza RF, Infantolino A, Dumot JA, Falk GW, Galanko JA, Jobe BA, Hawes RH, Hoffman BJ, Sharma P, Chak A, Lightdale CJ. Durability of radiofrequency ablation in Barrett’s esophagus with dysplasia. Gastroenterology. 2011 Aug;141(2):460-8. doi: 10.1053/j.gastro.2011.04.061. Epub 2011 May 6.
Zacharoulis D, Lazoura O, Sioka E, Potamianos S, Tzovaras G, Nicholls J, Koukoulis G, Habib N. Habib EndoHPB: a novel endobiliary radiofrequency ablation device. An experimental study. J Invest Surg. 2013 Feb;26(1):6-10. doi: 10.3109/08941939.2012.681832. Epub 2012 Dec 28.
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.
Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.
Monga A, Gupta R, Ramchandani M, Rao GV, Santosh D, Reddy DN. Endoscopic radiofrequency ablation of cholangiocarcinoma: new palliative treatment modality (with videos). Gastrointest Endosc. 2011 Oct;74(4):935-7. doi: 10.1016/j.gie.2010.10.018. Epub 2010 Dec 18.
Dolak W, Schreiber F, Schwaighofer H, Gschwantler M, Plieschnegger W, Ziachehabi A, Mayer A, Kramer L, Kopecky A, Schrutka-Kölbl C, Wolkersdörfer G, Madl C, Berr F, Trauner M, Püspök A; Austrian Biliary RFA Study Group.. Endoscopic radiofrequency ablation for malignant biliary obstruction: a nationwide retrospective study of 84 consecutive applications. Surg Endosc. 2014 Mar;28(3):854-60. doi: 10.1007/s00464-013-3232-9. Epub 2013 Oct 3.
Kallis Y, Phillips N, Steel A, Kaltsidis H, Vlavianos P, Habib N, Westaby D. Analysis of Endoscopic Radiofrequency Ablation of Biliary Malignant Strictures in Pancreatic Cancer Suggests Potential Survival Benefit. Dig Dis Sci. 2015 Nov;60(11):3449-55. doi: 10.1007/s10620-015-3731-8. Epub 2015 Jun 3.
Tal AO, Vermehren J, Friedrich-Rust M, Bojunga J, Sarrazin C, Zeuzem S, Trojan J, Albert JG. Intraductal endoscopic radiofrequency ablation for the treatment of hilar non-resectable malignant bile duct obstruction. World J Gastrointest Endosc. 2014 Jan 16;6(1):13-9. doi: 10.4253/wjge.v6.i1.13.
Wu F. Heat-Based Tumor Ablation: Role of the Immune Response. Adv Exp Med Biol. 2016;880:131-53. doi: 10.1007/978-3-319-22536-4_8. Review.
Witzigmann H, Berr F, Ringel U, Caca K, Uhlmann D, Schoppmeyer K, Tannapfel A, Wittekind C, Mossner J, Hauss J, Wiedmann M. Surgical and palliative management and outcome in 184 patients with hilar cholangiocarcinoma: palliative photodynamic therapy plus stenting is comparable to r1/r2 resection. Ann Surg. 2006 Aug;244(2):230-9.

Responsible Party: Tomas Hucl, Vice-chairman, Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03166436 History of Changes
Other Study ID Numbers: IKEM RFA CCA PC
Study First Received: May 14, 2017
Last Updated: May 23, 2017
Individual Participant Data
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Cholangiocarcinoma
Pancreatic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017