NCT04672642已完成不适用
Evaluation of the SpyGlass DS vs Standard Method for Detection of Residual Pancreatic Calculations After Endoscopic Treatment
Hospital St. Joseph, Marseille, France1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年7月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Residual pancreatic stones detected by the Spyglass DS
研究概览
简要总结
The purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 and over;
- •with chronic calcifying pancreatitis;
- •having already received endoscopic treatment for pancreatic pain related to stenosis and / or pancreatic stones;
- •having given free, informed and written consent;
- •being affiliated to a social security scheme or beneficiary of such a scheme.
排除标准
- •contraindications to performing an upper digestive endoscopy;
- •haemorrhagic disease, haemostasis and coagulation disorder (PR <60%, PTT> 40 s and platelets <60,000 / mm3;
- •pregnant or breastfeeding woman;
- •adult patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
- •person subject to a safeguard measure.
结局指标
主要结局
Residual pancreatic stones detected by the Spyglass DS
时间窗: baseline
rate of residual pancreatic stones detected by the SpyGlass DS, after a treatment by CT-scan and ERCP (recommended standard method) showing no stones in the Wirsung's duct. .
次要结局
- VAS score for pancreatic pain(preoperative, 1 month, 6 months and 12 months)
- Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)(baseline)
- Rate of patients hospitalized for pancreatic pain(12 months)
- Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain(12 months)
- Analgesic consumption(preoperative, 1 month, 6 months and 12 months)
- Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)(12 months)
- Self-administered quality of life questionnaire score(preoperative, 1 month, 6 months and 12 months)
- AE rate and type(during and immediately after the operation, 7 days, 1 month, 6 months and 12 months)
研究者
研究点 (1)
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