Photodynamic Therapy for Cholangiocarcinoma

NCT04860154 | Completed

• 1 other identifier: Photodynamic therapy
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Cholangiocarcinoma Non-resectable

Keywords

ERCP; PDT; Cholangiocarcinoma; Bile duct drainage; Stent

Outcome Measures

Primary Outcomes (2)

• Bile duct patency

  Patency period of the stents after treatment

  3years (every 3 months or obstruction appears)

• Median survival time

  The time of the half of the patients survived after initial therapy

  3years (every 3 months）

Secondary Outcomes (6)

• Overall survival

  5years (every 3 months）

• Karnofsky Performance Scale

  1year (baseline and every 3 months）

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30

  1year (baseline and every 3 months）

• The change of weight in kilograms

  1year (baseline and every 3 months）

• Beck Anxiety Inventory

  1year (baseline and every 3 months）

Study Arms (2)

PDT with stent

EXPERIMENTAL

Before photodynamic therapy, candidate patients undergoing biliary biopsy and biliary duct drainage. If pathology shows a bile duct malignancy, PDT therapy will carry out until total bilirubin drops below 100 μmol/L.Patients with negative skin test of hematoporphyrin Injection (3.0-5.0mg/Kg plus saline 250 mL intravenous drip, the drip was completed within 1 hour) and keep patients away from the light. The first PDT therapy was performed 24 hours after infusion of hematoporphyrin injection by ERCP. The biliary tumor necrosis was observed and the biliary tract was cleaned up 24 hours later and then PDT therapy showed again if necessary. Multiple plastic stents or metal stent will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.

Drug: Hematoporphyrin

ERCP stent

NO INTERVENTION

After obtaining bile duct biopsy, the candidates were placed with biliary plastic stents or metal stents directly.

Interventions

Hematoporphyrin DRUG

Patients with negative skin test of hematoporphyrin Injection (3.0-5.0mg/Kg plus saline 250 mL intravenous drip, the drip was completed within 1 hour) and keep patients away from the light. The first PDT therapy was performed 24 hours after infusion of hematoporphyrin injection by ERCP. The biliary tumor necrosis was observed and the biliary tract was cleaned up 24 hours later and then PDT therapy showed again if necessary. Multiple plastic stents or bald metal stents will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.

Also known as: ERCP stents

PDT with stent

Eligibility Criteria

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

You may qualify if:

• 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）;

You may not qualify if:

• Proximal cholangiocarcinoma (Bismuth type Ⅲ-Ⅳ, or intra-hepatic cholangiocarcinoma);
• Patients with Karnofsky Performance Scale (KPS) score≤70；
• Expected survival≤3months；
• Patients with porphyria；
• 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；
• Patients have intrahepatic metastasis or distant metastasis；
• Patients with no pathological diagnosis；
• known to allergic to study drug(porphyrin drugs) or other similar and related compounds；
• Other photosensitizers have been used within 4 weeks prior；
• Metal biliary stents were placed previously；
• Patients with contraindications to ERCP；
• Patients with HIV infection；
• Pregnant, parturient, or breastfeeding women；
• Patients complicated with other malignant tumors；

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (11)

Southwest Hospital, Army Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

General Hospital of Ningxia Medical University

Yingchuan, Ningxia, 750004, China

Location

The first affiliated hospital of Xi 'an JiaoTong university

Xi'an, Shaanxi, 710061, China

Location

Shandong Provincial Third Hospital

Jinan, Shandong, 250000, China

Location

Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

General Hospital of Taiyuan Iron and Steel Corporation

Taiyuan, Shanxi, 030008, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Related Publications (4)

• Lu Y, Liu L, Wu JC, Bie LK, Gong B. Efficacy and safety of photodynamic therapy for unresectable cholangiocarcinoma: A meta-analysis. Clin Res Hepatol Gastroenterol. 2015 Dec;39(6):718-24. doi: 10.1016/j.clinre.2014.10.015. Epub 2015 Jun 10.

  PMID: 26070572 BACKGROUND

• Gonzalez-Carmona MA, Bolch M, Jansen C, Vogt A, Sampels M, Mohr RU, van Beekum K, Mahn R, Praktiknjo M, Nattermann J, Trebicka J, Branchi V, Matthaei H, Manekeller S, Kalff JC, Strassburg CP, Weismuller TJ. Combined photodynamic therapy with systemic chemotherapy for unresectable cholangiocarcinoma. Aliment Pharmacol Ther. 2019 Feb;49(4):437-447. doi: 10.1111/apt.15050. Epub 2019 Jan 13.

  PMID: 30637783 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

• Talreja JP, Degaetani M, Ellen K, Schmitt T, Gaidhane M, Kahaleh M. Photodynamic therapy in unresectable cholangiocarcinoma: not for the uncommitted. Clin Endosc. 2013 Jul;46(4):390-4. doi: 10.5946/ce.2013.46.4.390. Epub 2013 Jul 31.

  PMID: 23964337 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Hematoporphyrins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors

Study Officials

• Xun Li, M.D.,Ph.D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director，M.D., Ph.D.

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 26, 2021
• Study Start: April 17, 2021
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)