Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

radiofrequency ablation

Intervention Type DEVICE

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.

S-1

Intervention Type DRUG

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.

Stent

Intervention Type DEVICE

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

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

Group Type PLACEBO_COMPARATOR

radiofrequency ablation

Intervention Type DEVICE

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.

Stent

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Stent

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

Intervention Type DEVICE

Other Intervention Names

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oral fluoropyrimidine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No