Validation of a Clinical Prediction Rule to Determine the Need for Repeat ERCP After Endoscopic Treatment of Postsurgical Biliary Leaks
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Absence of persistent bile leak
研究概览
简要总结
Post-surgical biliary leaks are relatively common after surgeries associated with hepatobiliary health. Left untreated, biliary leaks can lead to significant morbidity. Biliary leaks are most often successfully managed endoscopically, by way of performing an ERCP (endoscopic retrograde cholangio-pancreatography) procedure. These procedures help manage the bile leak by decreasing pressure at the opening of the common bile duct and promoting bile flow into the small bowel (rather than out the leak) via stent insertion.
Guidelines published by the American Society for Gastrointestinal Endoscopy (ASGE) report that stents are generally placed for 4 to 6 weeks and recommend longer intervals for more complex leaks. However, formal recommendations concerning the modality of biliary stent removal do not exist.
One option is performing a repeat ERCP when removing the stent. While comprehensive, this exposes the patient to additional radiation, and requires additional fluoroscopy resources and/or technicians. Furthermore, ERCPs are less available, especially in smaller centers, and are costly. A second option is a gastroscopy with simple stent removal has, given the low probability of requiring repeat intervention, the relatively low procedural cost, and the relatively favorable adverse event profile, and easier accessibility compared to ERCP procedures.
A simple, safe and reliable prediction rule was developed retrospectively to identify patients in whom biliary stent removal via gastroscopy could be safely performed, as opposed to repeat ERCP. A positive result using the rule requires satisfaction of four non-invasive clinical markers: (1) a normal post-surgical serum alkaline phosphatase value, (2) bile leak 'type C' at initial ERCP (a small or absent leak with no other biliary pathology), (3) a bile leak caused by laparoscopic cholecystectomy, and (4) a time between initial and follow-up endoscopy of 4 to 8 weeks. Validating this prediction rule prospectively could have implications on patient safety by decreasing ERCP-related adverse events, and could also have important implications with regard to health resource utilization.
详细描述
The previously developed prediction rule will be applied in a prospective fashion to consecutive patients undergoing ERCP for suspected post-surgical biliary leak. The same variables will be measured as in the initial study, but in this study, a research assistant (RA) will prospectively enter data and follow up with patients. For the purposes of this study, a second ERCP will be planned for stent removal and repeat cholangiogram (as per current practice). The sequence of procedures will be as follows:
Initial ERCP Visit:
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The patient is referred to PLC Endoscopy Unit for consideration of ERCP procedure for indication of post-surgical biliary leak and is booked by the attending advanced/therapeutic endoscopist on call as appropriate, as per the standard of care.
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Once verbal and written consent to approach has been given to their admitting nurse, patients will be approached by the RA prior to their procedure to discuss the actively enrolling study, and to answer any potential questions.
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If the patient agrees to participate, the informed consent form(s) is/are signed and witnessed. If the patient decides not to participate, the ERCP proceeds as per the usual standard of care (and the sequence that follows does not apply).
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The RA collects relevant patient-related and pre-procedural data through combination of direct patient interview and subsequent review of the medical records. Variables to be collected include:
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age
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gender
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presence of imaging evidence showing bile leak
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type of surgery performed
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time from surgery to ERCP
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Given that the patient will have already had an intravenous (IV) catheter placed on admission to the Endoscopy Unit (for purposes of receiving sedation or anesthesia during the procedure), a laboratory technician arrives to draw bloodwork from the patient to collect the following variables. If all following bloodwork has already been drawn for the patient within the preceding 24 hours prior to the procedure, no additional bloodwork will be drawn.
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complete blood count (CBC), including white blood cell count (WBC)
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gamma-glutamyl transferase (GGT)
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alkaline phosphatase (ALP)
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alanine aminotransferase (ALT)
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aspartate aminotransferase (AST)
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total and direct bilirubin
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international normalized ratio (INR)
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The patient is then met by the endoscopist performing the procedure to discuss the risks and benefits of the procedure and to have the patient sign informed consent for the procedure. The patient enters the endoscopy/fluoroscopy room and the procedure commences.
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During the procedure, peri-procedural data are recorded by the RA by direct observation, and/or, if necessary, in consultation with the procedural physician(s) and/or nurse(s). Variables to be collected include:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients having ERCP for suspected post-surgical biliary leak;
- •age 18 years or older
- •able to give informed consent to involvement.
排除标准
- •Unable or unwilling to provide informed consent;
- •age < 18 years;
- •non-surgical biliary leak;
- •previous ERCP with sphincterotomy;
- •previous treatment or attempted treatment of biliary leak;
- •unsuccessful initial ERCP.
结局指标
主要结局
Absence of persistent bile leak
时间窗: immediate
On repeat endoscopic evaluation absence of persistent bile leak or additional pathology will be evaluated
次要结局
未报告次要终点