NCT05519319

Brief Summary

A median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable EHCC. For patients with locally advanced, unresectable EHCC, effective management of tumor growth is the only option to increase stent patency and survival time. In patients with cholangiocarcinoma, photodynamic therapy (PDT) is therapy that has been shown to improve stent patency and overall survival (OS). Endoscopic radiofrequency ablation (RFA) has been demonstrated in numerous studies to prolong the life spans of individuals with malignant biliary obstruction . In the literature, comparing the clinical efficacy and adverse outcomes of these two endoscopic procedures is rare.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jan 2023Jun 2026

First Submitted

Initial submission to the registry

August 24, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

August 24, 2022

Last Update Submit

February 18, 2023

Conditions

Extrahepatic CholangiocarcinomaBile Duct Cancer

Keywords

Extrahepatic cholangiocarcinomaPhotodynamic therapyRadiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    OS was defined as the time from initial RFA or PDT to death or the end of the study.

    Three years

Secondary Outcomes (2)

  • Adverse events

    Three years

  • Progression-free survival(PFS)

    Three years

Study Arms (3)

Photodynamic therapy(PDT)

ACTIVE COMPARATOR

The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s.

Procedure: PDT

Radiofrequency ablation(RFA)

ACTIVE COMPARATOR

An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds.

Procedure: RFA

RFA+PDT

ACTIVE COMPARATOR

The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s. After that An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds.

Procedure: RFA combined with PDT

Interventions

RFAPROCEDURE

RFA will be performed

Also known as: ERCP guided
Radiofrequency ablation(RFA)
PDTPROCEDURE

PDT will be performed

Also known as: ERCP guided
Photodynamic therapy(PDT)
RFA combined with PDTPROCEDURE

RFA and PDT will be performed

Also known as: ERCP guided
RFA+PDT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed cholangiocarcinoma;
  • unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound（EUS）;
  • No previous treatment;
  • Adequate bone marrow and organ function (white blood cells\>4.0×109/L, hemoglobin\>90 g/L, and platelets\>75×109/L, serum creatinine\<2.0 mg/dl);
  • A Karnofsky performance status (KPS) score ≥ 50;
  • Signed written informed consent.

You may not qualify if:

  • Imaging examination (CT, MRCP, EUS) showed distant metastasis of liver, lung and other organs;
  • Coexistent with other malignant tumors;
  • Pregnant or nursing women;
  • Previous gastrointestinal diversion;
  • Participation in another study during the month before enrollment in this study;
  • Alcohol and/or substance abuse or potentially poor compliance per a doctor's judgment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

Related Publications (4)

  • Gao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24.

    PMID: 33359435BACKGROUND

  • Chen P, Yang T, Shi P, Shen J, Feng Q, Su J. Benefits and safety of photodynamic therapy in patients with hilar cholangiocarcinoma: A meta-analysis. Photodiagnosis Photodyn Ther. 2022 Mar;37:102712. doi: 10.1016/j.pdpdt.2022.102712. Epub 2022 Jan 5.

    PMID: 34995788RESULT

  • Li Z, Jiang X, Xiao H, Chen S, Zhu W, Lu H, Cao L, Xue P, Li H, Zhang D. Long-term results of ERCP- or PTCS-directed photodynamic therapy for unresectable hilar cholangiocarcinoma. Surg Endosc. 2021 Oct;35(10):5655-5664. doi: 10.1007/s00464-020-08095-1. Epub 2020 Oct 26.

    PMID: 33104917RESULT

  • 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: 29342492RESULT

MeSH Terms

Conditions

CholangiocarcinomaBile Duct Neoplasms

Interventions

1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBiliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Xiaofeng Zhang

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianfeng Yang, Doctor

CONTACT

+8613454132186yjf-1976@163.com, yjf3303@zju.edu.cn

Hayat Khizar, MD

CONTACT

+86137571474053180018940@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome Assessor are unaware about the results
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 29, 2022

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

CN(1)