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NCT04860154Completed

Photodynamic Therapy for Cholangiocarcinoma

Evaluation of Bile Duct Patency After Photodynamic Therapy in Unresectable Cholangiocarcinoma:a Prospective Non-randomized Controlled Study

Source: ClinicalTrials.gov · Last updated 20 Nov 2024

Brief summary (registry, in English)

Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma.

Status (registry)
Completed
Study type
Interventional
Enrollment
86 (actual)
First submitted
17 Apr 2021
Start date
17 Apr 2021
Primary completion date
19 Nov 2024
Lead sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
NCT number
NCT04860154

What you commit to

  • Study type: Interventional
  • Participants enrolled: 86
  • From 17 Apr 2021 to the primary completion date, 19 Nov 2024
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other photosensitizers have been used within 4 weeks prior;
  • Metal biliary stents were placed previously;
  • Patients with other contraindications for photodynamic therapy.

Other illness

  • known to allergic to study drug(porphyrin drugs) or other similar and related compounds;
  • Patients with HIV infection;
  • Patients complicated with other malignant tumors;
  • Patients with other serious physical or mental illnesses that prevent researchers to enroll them in this study as subjects;

Lab values

  • Coagulation dysfunction (INR\> 1.5) and low peripheral blood platelet count(\<50×10\^9 / L) or using anti-coagulation drugs;
  • Bilirubin could not be reduced to less than 100mmol/L within 1 month after drainage;

Other

  • Proximal cholangiocarcinoma (Bismuth type Ⅲ-Ⅳ, or intra-hepatic cholangiocarcinoma);
  • Patients with Karnofsky Performance Scale (KPS) score≤70;
  • Expected survival≤3months;
  • Patients with porphyria;
  • Patients have intrahepatic metastasis or distant metastasis;
  • Patients with no pathological diagnosis;
  • Patients with contraindications to ERCP;
  • Pregnant, parturient, or breastfeeding women;
  • Patients with severe liver function damage;
  • Patients who were in cachexia, liver abscess, or advanced patients who were unable to tolerate PDT;

Who the study is looking for

  • ERCP cholangiocarcinoma(the tumor is unresectable or patient can't accept surgery in the situation, the tumor can be resected but the patients cannot tolerate surgery);

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Southwest Hospital, Army Medical University
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ChongqingChinaUnknown status
The second Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
Shandong Provincial Third Hospital
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JinanChinaUnknown status
The First Hospital of Lanzhou University
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LanzhouChinaUnknown status
Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine
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ShanghaiChinaUnknown status
General Hospital of Taiyuan Iron and Steel Corporation
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TaiyuanChinaUnknown status
The First Affiliated Hospital of Xinjiang Medical University
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ÜrümqiChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
General Hospital of Ningxia Medical University
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YingchuanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.