NCT04301999

Brief Summary

The prognosis of patients with advanced unresectable EHCC is very poor with a median survival of 3 to 6 months. Active control of tumor growth is the key to extending stent patency and survival for patients with unresectable locally advanced EHCC. Photodynamic therapy (PDT) is by far the only modality that has shown to improve stent patency as well as over survival (OS) in patients with cholangiocarcinoma. In recent years, many studies have shown that endoscopic radiofrequency ablation (RFA) extends stent patency and possibly the survival of patients with malignant biliary obstruction. However, there are few reports comparing the clinical efficacy and advers event of these two endoscopic treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

March 6, 2020

Last Update Submit

August 27, 2021

Conditions

Cholangiocarcinoma

Keywords

extrahepatic cholangiocarcinomaPhotodynamic therapyradiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

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

    two years

Secondary Outcomes (2)

  • Adverse events

    two years

  • Progression-free survival (PFS)

    two years

Study Arms (2)

PDT group

ACTIVE COMPARATOR

Patients in PDT group underwnt PDT

Procedure: Photodynamic therapy

RFA group

EXPERIMENTAL

Patients in RFA group underwent RFA

Procedure: radiofrequency ablation

Interventions

Photodynamic therapyPROCEDURE

The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visualradiography. The dilation catheter was then withdrawn to leavethe 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.

Also known as: PDT
PDT group
radiofrequency ablationPROCEDURE

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.

Also known as: RFA
RFA group

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)

Jianfeng Yang

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Photochemotherapy1-phenyl-3,3-dimethyltriazeneRadiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapyRadiofrequency TherapyAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Jianfeng Yang

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of gastroenterology department

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

March 1, 2020

Primary Completion

August 27, 2021

Study Completion

August 27, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

CN(1)