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To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer
A majority of patients with oesophageal cancer present with inoperable disease and require rapid and long lasting palliation of dysphagia.
STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups.
PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oesophageal stent alone | Active Comparator | Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents |
|
| Oesophageal stent followed by EBRT | Active Comparator | Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oesophageal stenting with self expandable metal stent | Procedure | oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief of dysphagia | Relief of dysphagia will be assessed by stratifying the ability to swallow into the following grades. Grade 1: Difficulty in swallowing solid food Grade 2: Difficulty in swallowing semisolid food Grade 3: Difficulty in swallowing liquids Grade 4: Difficulty in swallowing even saliva The dysphagia scores will be assessed 1 week after intervention (stenting and radiotherapy)in the two groups | 1 week after intervention |
| Relief of dysphagia | Dysphagia grades at 3 months will be assessed in the two groups | 3 months following intervention |
| Relief of dysphagia | Dysphagia grades at 5 months will be assessed in the two groups | 5 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Patients will be followed up at baseline, 1 week after oesophageal stenting, 1 week after completion of radiotherapy and 2 monthly thereafter till their death | From the date of diagnosis till death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tushar K Chattopadhyay, MS | Head, Dept. G.I Surgery, All India Institute of Medical Sciences, New Delhi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7694321 | Background | Schmid EU, Alberts AS, Greeff F, Terblanche AP, Schoeman L, Burger W, Shiels RA, Friediger D, Van der Hoven A, Falkson G. The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial. Radiother Oncol. 1993 Jul;28(1):27-30. doi: 10.1016/0167-8140(93)90181-7. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069322 | Self Expandable Metallic Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| Oesophageal stent followed by external beam radiotherapy | Procedure | 30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group |
|
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |