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| ID | Type | Description | Link |
|---|---|---|---|
| MULEK-0254/281/2011 | Other Identifier | Medical University of Lublin |
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| Name | Class |
|---|---|
| St Johns' Oncology Center in Lublin | UNKNOWN |
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The objective of the study is comparison of the efficacy and safety of palliative therapy with single-dose brachytherapy or selfexpanding metal stents (SEMS) in malignant dysphagia resulting from adenocarcinoma of the esophago-gastric junction.
Over the past two decades it has been observed a clear trend in the increasing incidence of adenocarcinoma of the esophagus and esophago-gastric junction. More than half of these patients already have inoperable disease at presentation. Most of them need palliative treatment to relieve progressive dysphagia. Presently, endoscopic placement of a covered selfexpanding metal stent is the most commonly used method for treatment of malignant dysphagia. Cancer overgrowth and stent migration are the most common complications of endoscopic stenting and they occur more frequently with longer time from stenting. Specific location at esophago-gastric junction at the end point of the propulsive force after swallow may predispose stents for easier migration to the stomach. Additionally, the advances in chemotherapy have resulted in improved median survival of advanced adenocarcinoma ot the stomach and esophago-gastric junction even up to 10-12 months increasing a potential for higher chance for occurrence of stent complications. Brachytherapy has been proved to be a valuable and durable method to treat malignant dysphagia resulting from esophageal and mainly squamous cell cancer. For many years irradiation was not recommended for adenocarcinoma of the esophagus and esophago-gastric junction due to their putative low sensitivity to radiotherapy. Recently external beam radiation has been incorporated to a combined modality therapy regimens also for adenocarcinoma of the esophagus. Thus, brachytherapy could be an attractive and durable method for improving swallowing in adenocarcinoma of the esophago-gastric junction, as well. Single-dose brachytherapy and endoscopic stenting with SEMS in relieving dysphagia resulting from clearly defined adenocarcinoma of the esophago-gastric junction have not been compared yet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brachytherapy | Experimental | Single dose of 12 Gy generated using a flexible applicator containing Iridium 192 with the range of irradiation of 1cm from the applicator axis. The extent of irradiation will cover the whole length of cancer stricture and 2cm beyond proximal and distal end of the tumor. |
|
| Endoscopic Stenting | Other | Endoscopic stenting with partially covered selfexpandable metalic stents positioned across the cancer stricture and extending 2cm proximally and 2cm distally to the proximal and distal end of the tumor, respectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy | Radiation | Single dose of 12 Gy generated using a flexible applicator containing Iridium 192 with the range of irradiation of 1cm from the applicator axis. The extent of irradiation will cover the whole length of cancer stricture and 2cm beyond proximal and distal end of the tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| The highest improvement of dysphagia grade | 1 year | |
| Time to the best swallowing improvement | 1 year | |
| Time to recurrent worsening of swallowing | 1 year | |
| The highest improvement of stricture diameter | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| the procedure related morbidity | 1 year | |
| the procedure related mortality | 1 year | |
| The frequency of dysphagia related additional endoscopic interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Cost analysis | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Skoczylas, MD, PhD | Contact | +48 81 5328810 | tomskocz@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Skoczylas, MD, PhD | Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin | Principal Investigator |
| Krzysztof Zinkiewicz, MD, PhD | Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin | Recruiting | Lublin | Lublin Voivodeship | 20-081 | Poland |
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| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Endoscopic stenting | Procedure | Endoscopic stenting with partially covered selfexpandable metalic stents positioned across the cancer stricture and extending 2cm proximally and 2cm distally to the proximal and distal end of the tumor, respectively |
|
| 1 year |
| Overall survival | 1 year |
| Quality of life | 1 year |
| Principal Investigator |
| Grzegorz Wallner, Professor | Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin | Principal Investigator |
| Elżbieta Starosławska, MD, PhD | St Johns' Oncology Center in Lublin | Principal Investigator |
| Dariusz Kieszko, MD, PhD | St Johns' Oncology Center in Lublin | Principal Investigator |
|
| St. John's Cancer Center | Recruiting | Lublin | Lublin Voivodeship | 20-090 | Poland |
|
| D004935 |
| Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |