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临床试验/NCT06906029
NCT06906029尚未招募1 期

Abdominal aBscess Catheter Sclerotherapy (ABCS)

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年7月1日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Percentage of patients with VAS pain exceeding 7 following the catheter sclerotherapy or SIR grade 3 or higher complication.

研究概览

简要总结

This is a single center, two arm phase I/II clinical trial exploring the use of chemical sclerosants (ethanol and povidone iodine) in decreasing the time needed for catheter drainage for patients with non-fistulous intraabdominal abscesses. The target study sample size is 60 patients, 30 in each arm and abscess size is to be a minimum of 3cm in all 3 dimensions. The primary outcomes of interest will be tolerability and need for catheter reinsertion by one week post intervention.

详细描述

This is a two-arm prospective phase I/II clinical trial to assess the safety of a protocol of catheter-based drainage and povidone iodine or ethanol sclerotherapy of non-fistulous intraabdominal abscesses. The study aims to enroll approximately 60 total subjects with 30 per arm. The abscess should be intraperitoneal with a minimum diameter of 3cm in all three dimensions and devoid of suspicion for relation to a fistula. The described technique above will be employed to place a drainage catheter of minimum 14F in caliber and obtain an antimicrobial sample. Saline lavage will be performed by irrigating the abscess and aspirating the contents until the character of the instilled and aspirated fluid are similar. Following this step the cavity will be drained in full and a volume of approximately equal to the cavity of povidone iodine or ethanol will be instilled through the catheter with the catheter turned off to drainage. After approximately two minutes the drain will be opened to gravity and two minutes of additional time will be allotted to drain any excess povidone iodine or ethanol. The catheter will then be removed, and the site dressed with gauze and film dressing. The patient will then be followed clinically in the hospital for at least 48 hours and by phone check in for 7 days.

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
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

入选标准

  • Male or female, aged over 18years
  • Cross-sectional imaging (CT, US, MRI) showing an intraabdominal abscess measuring at last 3cm in each dimension without fistula to the bowel or skin.
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study

排除标准

  • Pregnancy or lactation
  • Known allergic reactions to povidone iodine or ethanol
  • Hemodynamic instability

研究组 & 干预措施

Iodine Arm

Active Comparator

Catheter-based drainage and povidone iodine sclerotherapy of non-fistulous intraabdominal abscesses.

干预措施: Catheter Sclerotherapy (Drug)

Ethanol Arm

Active Comparator

Catheter-based drainage and ethanol sclerotherapy of non-fistulous intraabdominal abscesses.

干预措施: Catheter Sclerotherapy (Drug)

结局指标

主要结局

Percentage of patients with VAS pain exceeding 7 following the catheter sclerotherapy or SIR grade 3 or higher complication.

时间窗: Baseline to day 7 plus or minus 7 days

Percentage of patients that will require reintervention for the same intrabdominal abscess within one week.

时间窗: Baseline to day 7 plus or minus 7 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Junaid Yasin Raja

Assistant Professor, Division of Interventional Radiology

University of Alabama at Birmingham

研究点 (1)

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