RFA for Malignant Biliary Obstruction

NCT03166436 | Unknown

• 1 other identifier: IKEM RFA CCA PC
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholangiocarcinoma; Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Survival

  number of days/months of survival (being alive) post intervention

  12 months

Secondary Outcomes (4)

• Stent patency

  12 months

• Complications

  30 days

• Quality of life

  12 months

• Augmentation of antitumor immunity

  30 days

Study Arms (2)

RFA plus stenting

EXPERIMENTAL

Endoluminal radiofrequency ablation followed by biliary stenting

Procedure: Radiofrequency ablation; Procedure: Biliary stenting

Stenting alone

ACTIVE COMPARATOR

Biliary stenting alone

Procedure: Biliary stenting

Interventions

Radiofrequency ablation PROCEDURE

radiofrequency ablation

RFA plus stenting

Biliary stenting PROCEDURE

biliary stenting

RFA plus stenting; Stenting alone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Unstable for ERC
• Inability to give informed consent
• Pregnancy
• Uncorrected coagulopathy
• Concomitant biliary oncological endoluminal therapy (photodynamic therapy, brachytherapy)
• Cardiac pacemaker

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Department of Gastroenterology and Hepatology

Prague, 14021, Czechia

RECRUITING

Related Publications (20)

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  PMID: 24140396 BACKGROUND

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  PMID: 23350673 BACKGROUND

• 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.

  PMID: 21620466 BACKGROUND

• 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. doi: 10.1016/0140-6736(92)92752-2.

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• 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.

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• 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

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• Curley SA, Izzo F. Radiofrequency ablation of primary and metastatic hepatic malignancies. Int J Clin Oncol. 2002 Apr;7(2):72-81. doi: 10.1007/s101470200010.

  PMID: 12018113 BACKGROUND

• 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.

  PMID: 21679712 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 25033929 BACKGROUND

• 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. No abstract available.

  PMID: 21168839 BACKGROUND

• Dolak W, Schreiber F, Schwaighofer H, Gschwantler M, Plieschnegger W, Ziachehabi A, Mayer A, Kramer L, Kopecky A, Schrutka-Kolbl C, Wolkersdorfer G, Madl C, Berr F, Trauner M, Puspok 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.

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• 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.

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• 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. doi: 10.1097/01.sla.0000217639.10331.47.

  PMID: 16858185 BACKGROUND

• Jarosova J, Zarivnijova L, Cibulkova I, Mares J, Macinga P, Hujova A, Falt P, Urban O, Hajer J, Spicak J, Hucl T. Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial. Gut. 2023 Nov 24;72(12):2286-2293. doi: 10.1136/gutjnl-2023-329700.

  PMID: 37652677 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma; Pancreatic Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Tomas Hucl, MD, PhD

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Hucl, MD, PhD

CONTACT

00420261362600; tomas.hucl@ikem.cz

Petra Truxova, Ing

CONTACT

00420261362619; petra.truxova@ikem.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-chairman, Department of Gastroenterology and Hepatology

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 25, 2017
• Study Start: June 8, 2017
• Primary Completion: May 8, 2019
• Study Completion: May 8, 2020
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)