跳至主要内容
临床试验/CTRI/2025/12/099651
CTRI/2025/12/099651尚未招募Phase 3 4

Prospective Comparative Study of Single vs Double Plastic Stents for Biliary Drainage in Patients of Malignant Distal CBD Obstruction Undergoing ERCP

Dr Hemanta Kumar Nayak1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
200
试验地点
1

研究概览

简要总结

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold-standard therapeutic procedure for managing biliary obstruction of both benign and malignant etiology. Biliary drainage via stent placement is essential in cases of cholestasis, cholangitis, or obstructive jaundice. Plastic stents (including straight and pigtail designs) and self-expandable metal stents (SEMS) are the two main types used.Plastic stents are commonly used due to their ease of insertion, cost-effectiveness, and suitability for temporary drainage especially in benign strictures, peri-procedural biliary decompression, or patients awaiting surgery. The double-pigtail plastic stent (DPT) has become the preferred choice due to its ability to minimize migration, anchor securely across strictures, and reduce perforation risk .

In malignant biliary strictures, studies suggest multiple stents (especially SEMS) can offer better patency and less dysfunction than a single stent.

Some advantages Hypothesized for Double DPT Stents are·         Enhanced biliary drainage due to increased stent lumen availability.

·         Lower risk of stent occlusion or early dysfunction.

·         Reduced need for early re-intervention.

·         Better anchorage in dilated CBDs, reducing risk of migration.

However, some concerns with double Stents are·         Increased procedural time.

·         Technical difficulty in placing two stents.

·         Theoretical increase in cost and risk of post-ERCP pancreatitis or cholangitis.

There is currently no randomized trial comparing single vs double DPT stents in a homogenous population undergoing ERCP for biliary drainage—whether in benign strictures, pre-operative decompression, or palliative settings. There is lack of consensus or guideline recommendations on optimal number of plastic stents in ERCP for non-hilar obstruction.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18 to 80 years.
  • 2.Indicated for biliary drainage by ERCP (malignant obstruction.
  • 3.CBD diameter greater than 8 mm.
  • 4.Distal CBD or mid-distal CBD block.
  • 5.Written informed consent.

排除标准

  • 1.Previous biliary stenting.
  • 2.Coagulopathy (INR greater than 1.5 or platelets less than 50,000).
  • 3.Severe comorbidities (e.g., advanced cardiac or renal disease).
  • 4.Pregnancy.
  • 5.Altered anatomy preventing standard ERCP.

研究者

发起方
Dr Hemanta Kumar Nayak
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Hemanta Kumar Nayak

AIIMS, Bhubaneswar

研究点 (1)

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