Endobiliary Radiofrequency Ablation With S-1 for Unresectable Cholangiocarcinoma

NCT02592538 | Completed DMC

• 1 other identifier: 2002-001-003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

Biliary duct carcinoma;; radiofrequency ablation; S-1

Outcome Measures

Primary Outcomes (1)

• survival time

  Compare overall survival time in patients with unresectable cholangiocarcinoma treated with RFA combined with or without S-1

  two years

Secondary Outcomes (3)

• adverse events

  two years

• frequency of repeat RFA

  two years

• the frequency of cholangitis

  two years

Study Arms (2)

RFA+stent+S-1

EXPERIMENTAL

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; Drug: S-1; Device: Stent

RFA+stent

PLACEBO COMPARATOR

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; Device: Stent

Interventions

radiofrequency ablation 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.

RFA+stent; RFA+stent+S-1

S-1 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.

Also known as: oral fluoropyrimidine

RFA+stent+S-1

Stent DEVICE

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

RFA+stent; RFA+stent+S-1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

Location

Related Publications (5)

• Laquiere A, Boustiere C, Leblanc S, Penaranda G, Desilets E, Prat F. Safety and feasibility of endoscopic biliary radiofrequency ablation treatment of extrahepatic cholangiocarcinoma. Surg Endosc. 2016 Mar;30(3):1242-8. doi: 10.1007/s00464-015-4322-7. Epub 2015 Jul 11.

  PMID: 26162420 BACKGROUND

• Butros SR, Shenoy-Bhangle A, Mueller PR, Arellano RS. Radiofrequency ablation of intrahepatic cholangiocarcinoma: feasability, local tumor control, and long-term outcome. Clin Imaging. 2014 Jul-Aug;38(4):490-494. doi: 10.1016/j.clinimag.2014.01.013. Epub 2014 Feb 7.

  PMID: 24637151 BACKGROUND

• Strand DS, Cosgrove ND, Patrie JT, Cox DG, Bauer TW, Adams RB, Mann JA, Sauer BG, Shami VM, Wang AY. ERCP-directed radiofrequency ablation and photodynamic therapy are associated with comparable survival in the treatment of unresectable cholangiocarcinoma. Gastrointest Endosc. 2014 Nov;80(5):794-804. doi: 10.1016/j.gie.2014.02.1030. Epub 2014 May 15.

  PMID: 24836747 BACKGROUND

• Yang J, Wang J, Zhou H, Wang Y, Huang H, Jin H, Lou Q, Shah RJ, Zhang X. Endoscopic radiofrequency ablation plus a novel oral 5-fluorouracil compound versus radiofrequency ablation alone for unresectable extrahepatic cholangiocarcinoma. Gastrointest Endosc. 2020 Dec;92(6):1204-1212.e1. doi: 10.1016/j.gie.2020.04.075. Epub 2020 May 11.

  PMID: 32437711 DERIVED

• Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.

  PMID: 29342492 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Radiofrequency Ablation; S 1 (combination); Stents

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostheses and Implants; Equipment and Supplies

Study Officials

• Xiaofeng Zhang, M.S

  First People's Hospital of Hangzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy irector

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: March 1, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

CN (1)