NCT00004910已完成1 期
A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery.
PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.
详细描述
OBJECTIVES:
- Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents.
- Evaluate the efficacy and safety of this treatment in these patients.
- Evaluate the quality of life of these patients after enteral Wallstent placement.
OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum.
Quality of life is assessed at 48 hours and 6 months after procedure.
Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Endoscopically confirmed localized tumor as the cause of duodenal obstruction
- •All primary tumor types are eligible
- •No prior duodenal Wallstents
- •Must have symptoms of gastrointestinal obstruction, including:
- •Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count greater than 50,000/mm^3
- •INR no greater than 1.5 times upper limit of normal
- •Not specified
- •Cardiovascular:
- •No cardiac condition
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No significant active infection (e.g., pneumonia, peritonitis, or wound abscess) that would preclude endoscopy
- •No other serious concurrent illness
- •No uncontrolled metabolic disease (e.g., diabetes mellitus or hypothyroidism)
- •No dementia, psychiatric disorder, or altered mental status that would preclude compliance
- •History of other neoplastic disease allowed
- •Veterans Administration patients are not eligible
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Prior or concurrent chemotherapy allowed
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior or concurrent radiotherapy allowed
- •At least 3 weeks since prior surgery and recovered
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel ObstructionConstipation, Impaction, and Bowel ObstructionGastrointestinal Carcinoid TumorQuality of LifeSmall Intestine CancerColorectal CancerGastric CancerGastrointestinal Stromal TumorNCT00004911Northwestern University
尚未招募
不适用
Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel DiseaseInflammatory Bowel DiseasesBowel StrictureNCT06725563Ottawa Hospital Research Institute20
已完成
不适用
AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE StudyWalled Off Pancreatic NecrosisNCT03525808Boston Scientific Corporation40
招募中
不适用
Efficacy of a new Wallflex Duodenal Soft stent for palliation of gastric outlet obstructioNL-OMON24271Erasmus MC20
招募中
不适用
Endoscopic Stenting versus Operative Intervention in Malignant Gastric Outlet Obstruction.Malignant gastric outlet obstructionDutch: maaguitgangstenoseNL-OMON28881Erasmus Medical Center Rotterdam, Department of Gastroenterology and Hepatology100