Neoplasms

All Conditions

Rare Diseases

Klatskin Tumor

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Patients who underwent photodynamic therapy for malignant biliary obstruction.

Photodynamic therapy using polyhematoporphyrin

Werner Dolak, M.D.

Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction. The aim of this study is to assess the feasibility and safety of this technique in the context of a nationwide retrospective analysis.

INTRODUCTION

Malignant biliary obstruction is a life threatening condition in patients suffering from primary or secondary bile duct malignancies. Palliative therapies aim to prevent complications associated with the obstruction. Photodynamic therapy (PDT) aims to reduce the local tumor mass by inducing tumor necrosis after light activation of a photosensitizer during endoscopic retrograde cholangiography (ERC).

STUDY AIMS

The aim of the present study is to evaluate the feasibility and safety of PDT with polyhematoporphyrin, the photosensitizer most commonly used for PDT in Austria, in the context of a nationwide analysis.

METHODS

This retrospective study will be conducted at seven Austrian referral centers for bilio-pancreatic endoscopy. The study protocol was approved by the internal review board of the Medical University of Vienna (EK 1448/2012). Patients who underwent PDT with polyhematoporphyrin as therapy for malignant biliary obstruction after 2004 will be identified using examination report databases. Examination reports and patient charts will be analyzed to assess underlying diseases, oncological co-therapies, intra-procedural adverse events, hospital stay, adverse events within 30 days post intervention as well as 30-day, 90-day, and overall mortality. All patient data will be de-identified using pseudonymization prior to any further processing. Descriptive statistics will be used to present the study parameters. Survival will be assessed using Kaplan-Meier statistics and compared between the different underlying tumor entities using the Log Rank test. Cox regression will be used to identify independent predictors of survival. Significant factors at univariate analysis will be entered into multivariate testing. P-values less than 0.05 will be considered significant. SPSS version 23.0 will serve for data analysis.

Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction

Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction - a Retrospective Analysis.

Overall survival as surrogate marker of treatment efficacy

Medical University of Vienna

Assistant doctor

Symptoms and General Pathology

Digestive System Diseases

Constriction, Pathologic

Cholestasis

Pathological Conditions, Anatomical

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Self-expandable metallic stent will be inserted for the malignant hilar obstruction.

DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.

Self-expandable metallic stent will be inserted for malignant hilar obstruction.

SEMS insertion

DoubleLayer plastic stent will be inserted for malignant hilar obstruction.

DLS insertion

Do Hyun Park, MD

Tae Hoon Lee, MD

Jung Sik Choi, MD

Sang Woo Cha, MD

The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months.

There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction.

The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.

Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture

Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial

Interval time (d) from stent insertion to occlusion

Early or Late complications

* asymptomatic hyperamylasemia
* pancreatitis (mild/moderate/severe)
* cholecystitis
* cholangitis
* recurrent jaundice
* Internal migration
* external migration
* occlusion

Total Cost for SEMS and DLS group

* ERCP cost
* Total ERBD cost (DLS or metal)
* Total hospitalization cost
* Cost for session x No. of session
* Total (DLS vs. metal)cost /session

* Successful insertion of bilateral or unilateral stent insertion.
* Time to adequate expansion (70% of maximal expanded diameter was dilated state) in metal stent ≤ 24 hrs
* No stent migration within 24 hrs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction	NCT02504957	Klatskin's Tumo...	Photodynamic th...	-	Medical University of Vienna
Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction	NCT02504957	Klatskin's Tumo...	Photodynamic th...	-	Medical University of Vienna
Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture	NCT01125865	Bile Duct Obstr... Klatskin's Tumo...	SEMS insertion DLS insertion	18 Years -	Soon Chun Hyang University

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