NCT01739465

Brief Summary

The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

November 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

February 26, 2013

Status Verified

February 1, 2013

Enrollment Period

3.1 years

First QC Date

November 29, 2012

Last Update Submit

February 25, 2013

Conditions

Cholangiocarcinoma

Keywords

CholangiocarcinomaPathologicDigestive SystemNeoplasmsNeoplasms by SiteDigestive System DiseasesBile Duct DiseasesBiliary Tract DiseasesPathological ConditionsConstrictionAdenocarcinomaCarcinoma

Outcome Measures

Primary Outcomes (1)

  • stent patency

    6 months

Secondary Outcomes (1)

  • overall survival rate

    3 years

Study Arms (3)

Self expanding metallic stent （SEMS ）placement only

ACTIVE COMPARATOR

Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing

Procedure: Self expanding metallic stent (SEMS)

Endoscopic radiofrequency ablation plus SEMS

EXPERIMENTAL

Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing

Procedure: Self expanding metallic stent (SEMS)Procedure: Endoscopic radiofrequency ablation (ERFA)

Photodynamic therapy plus SEMS

EXPERIMENTAL

Photofrin is injected 3 days prior to laser activation of the agent.Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) will be carried out to determine the length and positon of the biliary malignant. Delivery Fiber used along with the laser system to activate the photosensitizing agent and induce tumor tissue necrosis. A self expanding metallic stent (SEMS) will be placed the site of biliary narrowing

Procedure: Self expanding metallic stent (SEMS)Procedure: Photodynamic therapy (PDT)

Interventions

Self expanding metallic stent (SEMS)PROCEDURE

Self expanding metallic stent

Endoscopic radiofrequency ablation plus SEMSPhotodynamic therapy plus SEMSSelf expanding metallic stent （SEMS ）placement only
Endoscopic radiofrequency ablation (ERFA)PROCEDURE

Endoscopic radiofrequency ablation

Endoscopic radiofrequency ablation plus SEMS
Photodynamic therapy (PDT)PROCEDURE

Photodynamic therapy

Photodynamic therapy plus SEMS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old
  • Pathologically or radiologically confirmed biliary malignant
  • Inoperability by staging

You may not qualify if:

  • Cholangiocarcinoma with widespread metastasis
  • Coagulopathy (INR \> 2.0 or prothrombin time \> 100 sec or platelet count \< 50,000)
  • Prior SEMS placement
  • Pregnancy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
  • Life expectancy \< 3months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Second Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510260, China

NOT YET RECRUITING

The second hospital of Guangzhou Medical college

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

CholangiocarcinomaNeoplasmsNeoplasms by SiteDigestive System DiseasesBile Duct DiseasesBiliary Tract DiseasesConstriction, PathologicAdenocarcinomaCarcinoma

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Central Study Contacts

Huihong Liang, MD

CONTACT

+86-20-34153043beanth@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 3, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2015

Last Updated

February 26, 2013

Record last verified: 2013-02

Locations

CN(2)