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临床试验/NCT04535440
NCT04535440Unknown不适用

To Describe the Clinical, Endoscopic and Endoscopic Ultrasound Features of Non-bleeding and Bleeding Rectal Varices, Among Patients With Portal Hypertension.

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Anatomical and liver -related risk-factors for presence of rectal varices (RV) among patients with portal hypertension

研究概览

简要总结

Rectal varices (RVs) are an important cause of lower gastrointestinal bleed (LGIB) in portal hypertension (PHT) and have been reported to occur in 44% to 89% of cases of cirrhosis. RVs are dilated sub-mucosal porto-systemic communications which extend from mid rectum to the ano-rectal junction and are considered distinct from internal hemorrhoids, which are submucosal arterio-venous communications of the anorectal vascular plexus. The suspicion of RVs as the cause of bleeding can be made with a high index of suspicion when lower GI bleed is seen in absence of hemorrhoids, and colonoscopy shows blood in rectum. Bleeding usually happens from endoscopically evident rectal varices (EERV) but sometimes bleed can occur from varices, which are endoscopically in evident (EIERV). Endoscopic ultrasound (EUS) has been shown to be more sensitive in diagnosis of EIERV. Endoscopic and EUS correlation of RVs has shown that RVs, classified as tortuous, nodular, and tumorous on endoscopic examination, have corresponding appearances on rectal EUS as single, multiple, and innumerable submucosal veins, respectively. The hemodynamic evaluation (HDE) of RVs by EUS is routinely done at some centers to assess parameters like the site, size, velocity, or direction of flow.

详细描述

AIM:

To describe the clinical, radiological, endoscopic and endoscopic-ultrasound features of non-bleeding and bleeding rectal varices, among patients with portal hypertension.

OBJECTIVES:

Primary objectives:

Anatomical and liver -related risk-factors for presence of rectal varices (RV) among patients with portal hypertension Secondary objectives

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18-years.
  • Patients with PHT and active or prior anorectal bleeding in preceding 6-months.
  • Patients with RV (bleeding or non-bleeding) detected on LGI endoscopy.
  • Ability to understand study procedures, and to comply with them for the entire length of the study.

排除标准

  • Peri-anal infection, peri-anal warts, anal condyloma, or fistulizing disease.
  • Proctitis- infective, inflammatory bowel disease (IBD), radiation, or unspecified.
  • Pregnant or lactating females.
  • Presence of hemodynamic instability.
  • Presence of encephalopathy
  • Non-consenting adult patient or guardian.
  • Prior history of banding or surgery for hemorrhoids, or endotherapy for RV.
  • Prior shunt occlusion procedures like BRTO or PARTO, or shunt creation procedures like TIPS.

结局指标

主要结局

Anatomical and liver -related risk-factors for presence of rectal varices (RV) among patients with portal hypertension

时间窗: Day 1

次要结局

  • Etiological spectrum of bleeding per-rectum, among patients with PHT.(Day 1)
  • Frequency of coexistence of hemorrhoids with Rectal varices(Day 1)
  • Distribution and size of variceal channels in the rectum on endoscopy and endoscopic ultrasound (EUS).(Day 1)
  • Location and numbers of inflow and outflow perforator channels for RV on endoscopic ultrasound (EUS).(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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