Feasibility and Safety of Intraoperative Bile Duct Clearance by Sphincter of Oddi Balloon Dilatation: A Prospective Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Rate of successful bile duct stone clearance (feasibility)
研究概览
简要总结
To investigate feasibility and safety of intraoperative bile duct clearance by sphincter of Oddi balloon dilatation via cystic duct at cholecystectomy.
Primary endpoint: rate of successful bile duct stone clearance (feasibility). Secondary endpoints (safety): rate of peri-interventional complications (injury to the common bile duct, bleeding, injury to surrounding organs: stomach, duodenum, liver) and short-term postoperative complications (bile leak, cholangitis, lipasaemia, pancreatitis, pneumonia). Duration of procedure. Length of hospital stay.
详细描述
Standard approach to address common bile duct stones is endoscopic retrograde cholangiography (ERC) with sphincterotomy. Those interventions are performed either before or after gallbladder removal (cholecystectomy), thus, requiring at least two interventions. Moreover, ERC with sphincterotomy is associated with a considerable rate of short and long-term morbidity. The main complications are pancreatitis (2-7%), post sphincterotomy bleeding (1-2%), impaired function of the sphincter with reflux of duodenal content to the bile ducts and a consecutive risk for cholangitis, stone recurrence and even a potential higher risk for cholangiocarcinoma.
The aim of this study is to evaluate an alternative surgical approach of bile duct clearance at the time of cholecystectomy. Literature of this approach is scarce; however, it has shown a trend to lower postoperative complications if compared to ERC. The technique of sphincter of Oddi balloon dilatation and bile duct clearance from stones via cystic duct at cholecystectomy has been described in a few case series. These small case series have shown a good success rate of bile stone clearance and low complication rates when applying the balloon dilation technique for smaller stones.
The investigators have used this technique in selected cases with good success as well. However, the technique needs to be assessed regarding feasibility and safety in a consecutive group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Patients ≥ 18 years of age
- •Patients with gallbladder stones and known or expected concomitant bile duct stones
- •Bile duct stones ≤ 6mm in size measured by intraoperative cholangiography
排除标准
- •Women who are pregnant
- •Declined consent
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Patients with moderate or severe acute cholangitis
- •Patients with moderate or severe pancreatitis
研究组 & 干预措施
Papillary ballon dilatation
干预措施: Papillary ballon dilatation (Procedure)
结局指标
主要结局
Rate of successful bile duct stone clearance (feasibility)
时间窗: At the 6 week follow up appointment
Patient not showing any signs of choledocholithiasis (fever, pale stool, dark urine, right upper quadrant pain, elevated cholestasis parameters) at 6 week follow up
Rate of successful bile duct stone clearance (feasibility)
时间窗: During operation, up to 2 hours
Intraoperative cholangiogram showing no persistent stones in the common bile duct after the study procedure
次要结局
- Number of patients with injury to common bile duct(During operation, up to 2 hours)
- Intraoperative blood loss(During operation, up to 2 hours)
- Intraoperative blood substitution(During operation, up to 2 hours)
- Number of patients with lesion to surrounding organs(During operation, up to 2 hours)
- Number of patients with postoperative bile leak(From operation up to 6 weeks postoperative)
- Number of patients with postoperative significant bleeding(From operation up to 6 weeks postoperative)
- Number of patients with postoperative cholangitis(From operation up to 6 weeks postoperative)
- Number of patients with postoperative lipasaemia(4 hours after the operation)
- Number of patients with postoperative acute pancreatitis(From operation up to 6 weeks postoperative)