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临床试验/NCT05068739
NCT05068739已完成不适用

Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation

Duzce University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月1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
80
试验地点
2
主要终点
Success rate of cannulation

研究概览

简要总结

The aims of this study are to compare the needle knife fistulotomy (NKF) technique versus the partial ampullary endoscopic mucosal resection (PA-EMR) technique in patients with difficult biliary cannulation and to assess the incidence rate of complications between these cannulation methods.

详细描述

Cannulation success with standard techniques reported to be around 95% even in expert hands and despite all efforts, it can be challenging that needs an alternate intervention.

NKF is recommended as the initial technique for pre-cutting because the rate of post-ERCP pancreatitis (PEP) is significantly low but there is an ongoing debate about limiting its use in certain types of papillae with a long intra-mural segment

Indeed the shape of the papillae influences the success of bile duct cannulation and the choice of the pre-cutting technique. Type-2 and Type-3 papillae are more difficult to cannulate than Type-1. NKF can be performed as the initial technique for pre-cutting in protruded Type-2 and Type-3 papillae but it has some limitations.

First of all, the incision can be erratic because it is performed without a guidewire and uncontrolled. This can cause a tattered mucosa as the incision progress and the papillae lose anatomic contours. Some amount of bleeding may also unavoidably occur and the field of view further impaired. If the initial incision line is incorrect and additional incision is needed, more crumpled and deformed papillae with irregular margins may be encountered. These undesired results are frequently experienced and prevent a clean-cut, thus further complicate the cannulation. Even perforation can occur.

Recently the investigators described a novel technique, PA-EMR, for difficult biliary cannulation in patients with protruded Type-2, Type-3, and shar-pei papilla. The investigators hypothesized that with this new technique cannulation success will be higher, procedure time will be shorter and the adverse events will be lower versus NKF technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who submitted a written informed consent for this trial, and aged between 18-90 years old
  • Patient who have naïve papilla (no previous procedure was performed at ampulla)
  • Patient who is suspected to have a biliary obstruction or biliary disease
  • Patient who is needed to have endoscopic retrograde cholangiopancreatography for treatment of biliary obstruction
  • Patient who have risks of post-endoscopic retrograde cholangiopancreatography p

排除标准

  • Patient who is pregnant
  • Patient with mental retardation
  • Patient allergic to contrast agents
  • Patient who received sphincterotomy or pancreatobiliary operation previously
  • Patient who have ampulla of Vater cancer
  • Patient who have difficulty for the approach to ampulla due to abdominal surgery including stomach cancer with Billroth II anastomosis
  • Patient who have pancreatic diseases as bellow (at least one more);
  • acute pancreatitis within 30days before enrollment
  • idiopathic acute recurrent pancreatitis
  • pancreas divisum
  • obstructive chronic pancreatitis
  • pancreatic cancer
  • Patients with Type-1, non-protruding Type-2 and Type-4 papilla

结局指标

主要结局

Success rate of cannulation

时间窗: 1 day

Successful bilary cannulation, verified by fluoroscopic images of correct guidewire positioning in the CBD, and contrast media.

次要结局

  • Incidence rate of complications(1 week)
  • Cannulation time(1 day)
  • Procedure time(1 day)

研究者

发起方
Duzce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Salih Tokmak

Asisstant Professor

Duzce University

研究点 (2)

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