A Randomized Study of "Roll-over' Technique With Standard Abdominal Paracentesis to Improve Cytological Yield in Patients Suspected to Have Peritoneal Carcinomatosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Yield of malignant cells
研究概览
简要总结
The study will be a randomized trial that will compare two techniques of abdominal paracentesis in patients with suspected peritoneal carcinomatosis. The patients will undergo abdominal paracentesis by the standard technique and a rollover technique. In the standard technique, the patients will lie flat for 10 minutes and abdominal paracentesis will be taken for ascitic fluid cytology. In the rollover group, patients with suspected peritoneal carcinomatosis will be rolled over thrice laterally on each side by 90 degrees and sample will then be obtained for ascitic fluid cytology. both the samples will be processed by blinded cytopathologist for tumour cellularity and diagnostic yield.
详细描述
Trial Design
The study will be a randomized comparison between two methods of abdominal paracentesis with a cross-over design and each participant will also serve as a control (standard paracentesis).
Participants
The study will be done on the patients who will visit Outpatient departments or admitted as an inpatient in the Post Graduate Institute of Medical Education and Research, Chandigarh.
Screening population: All patients with ascites
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with ascites where a diagnosis of peritoneal carcinomatosis is being considered on the basis of one or more of the following
- •Clinical Suspicion of peritoneal carcinomatosis on basis of a history of malignancy, painful ascites and/or loss of weight
- •Clinical Suspicion of peritoneal carcinomatosis on the basis of presence of ascites with lump or other stigmata of malignancy
- •Suspicion of peritoneal carcinomatosis on imaging suggestive of peritoneal carcinomatosis
排除标准
- •Age < 12 years
- •Refusal to participate or provide consent
- •Evidence of chronic liver disease-related ascites (evidence of cirrhosis on ultrasonography or evidence of portal hypertension eg varices on endoscopy)
- •Already diagnosed alternate cause of ascites like cirrhosis, pancreatitis, right heart failure -
- •Contraindications to paracentesis in the form of disseminated intravascular coagulation or local site infection.
结局指标
主要结局
Yield of malignant cells
时间窗: One month
Number of samples reported positive for malignant cells out of the cases of peritoneal carcinomatosis
次要结局
- Cellularity of the smear of the smear(One day)
研究者
Vishal Sharma
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh