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Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT02592538
Recruitment Status : Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jianfeng Yang, First People's Hospital of Hangzhou

Brief Summary:
Endobiliary radiofrequency ablation (RFA) with biliary stent has been reported to be a beneficial treatment option for palliation of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased tumor ingrowth. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma. The aim of this study is to evaluate the combined effect of RFA and S-1 in patients with unresectable cholangiocarcinoma.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Device: radiofrequency ablation Drug: S-1 Device: Stent Not Applicable

Detailed Description:

Over 60 % of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of metal or plastic stents for palliation is the therapy of choice in this set of patients.

Radiofrequency ablation (RFA) is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Many studies showed RFA with biliary stent was a beneficial treatment option for palliation of malignant biliary strictures. However, most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1, an oral fluoropyrimidine, was reported as effective in patients with bile duct adenocarcinoma. To date, little is known about the role of the addition of systemic chemotherapy to RFA for cholangiocarcinoma.

The aim of this study is to conduct a randomised, controlled, clinical trial to compare the effect of S-1 plus RFA with stent with RFA with stent in patients with unresectable cholangiocarcinoma.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endobiliary Radiofrequency Ablation With S-1 in Patients With Unresectable Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control
Study Start Date : February 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RFA+stent+S-1
Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Patients will receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement, and be treated with S-1 began within 1 month after RFA.
Device: radiofrequency ablation
All patients underwent biliary sphincterotomy. Cholangiogram was performed to confirm stricture location, length and diameter. The Habib Endo HPB (Hepatobiliary) probe (EMcision, HitchinHerts, UK) was then advanced over a wire at the level of the biliary stricture and ablation using ERBE generator set at 7-10 watts for a time period of 90-120 s was conducted. A 1- to 2-min resting period after energy delivery was allowed before moving the catheter along the length of the stricture to ablate the rest of the stricture.

Drug: S-1
In the RFA plus S-1 group, treatment with S-1 began within 1 month after RFA. Based on the patient's body surface area, S-1 was administered as follows: when the level of total bilirubin was less than 2 mg/dl. Based on the body surface area, S-1 was administered if <1.25 m2, 80 mg/day; if 1.25-1.5 m2, 100 mg/day; if≥1.5 m2, 120 mg/day. S-1 was administered orally twice daily for 14 days, followed by 7 days without treatment.
Other Name: oral fluoropyrimidine

Device: Stent
Plastic stent(s) were placed after RFA depending on the location of the malignant obstruction

Placebo Comparator: RFA+stent
Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Patients will only receive endobiliary radiofrequency ablation ( RFA) followed by plastic stent(s) placement
Device: radiofrequency ablation
All patients underwent biliary sphincterotomy. Cholangiogram was performed to confirm stricture location, length and diameter. The Habib Endo HPB (Hepatobiliary) probe (EMcision, HitchinHerts, UK) was then advanced over a wire at the level of the biliary stricture and ablation using ERBE generator set at 7-10 watts for a time period of 90-120 s was conducted. A 1- to 2-min resting period after energy delivery was allowed before moving the catheter along the length of the stricture to ablate the rest of the stricture.

Device: Stent
Plastic stent(s) were placed after RFA depending on the location of the malignant obstruction




Primary Outcome Measures :
  1. survival time [ Time Frame: two years ]
    Compare overall survival time in patients with unresectable cholangiocarcinoma treated with RFA combined with or without S-1


Secondary Outcome Measures :
  1. adverse events [ Time Frame: two years ]
    Number of participants with adverse events; type, frequency and intensity of adverse events

  2. frequency of repeat RFA [ Time Frame: two years ]
  3. the frequency of cholangitis [ Time Frame: two years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obtention of a written informed consent.
  • Patient over 18.
  • Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
  • Patient with Karnofsky score ≥ 50 %
  • Patient capable of fill in the quality of life questionnaire.

Exclusion Criteria:

  • No written informed consent.
  • Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
  • Patients with porphyria or hypersensibility to porphyrins.
  • Pregnant, parturient or breastfeeding women.
  • Patient under 18.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592538


Locations
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China, Zhejiang
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 31006
Sponsors and Collaborators
First People's Hospital of Hangzhou
Investigators
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Study Director: Xiaofeng Zhang, M.S First People's Hospital of Hangzhou

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jianfeng Yang, Deputy irector, First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT02592538     History of Changes
Other Study ID Numbers: 2002-001-003
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jianfeng Yang, First People's Hospital of Hangzhou:
Biliary duct carcinoma;
radiofrequency ablation
S-1
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms