A Randomized Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Proportion of patients with no recurrence of hemorrhoidal bleeding episodes at 1 week after endotherapy.
研究概览
简要总结
Haemorrhoids are the most common proctologic disease, affecting up to 36% of people in the developed world. Sclerotherapy is defined as the injection of sclerosing agents at the apex of the internal hemorrhoidal complex, above the dentate line, leading to scarring, fibrosis, and fixation of the hemorrhoids. Sclerotherapy as a treatment of internal hemorrhoids has been used for a long time by surgeons, using proctoscopic exposure. Even though flexible instruments can be expected to have better manoeuvrability and target site exposure. There is no consensus amongst the major guidelines as to which grade of haemorrhoid that sclerotherapy should be used, whether it is equivalent or inferior to rubber bad ligation (RBL), whether sclerotherapy should be used at all for the treatment of IH, what is the effect of PHT on hemorrhoid prevalence and propensity to bleed, differentiation of internal hemorrhoids from rectal varices, data on EBL or EST in cirrhotics with hemorrhoids, safety of endotherapy with underlying coagulopathy and concerns for infectious complications.
详细描述
Hypothesis :- Polidocanol foam sclerotherapy is more effective than liquid polidocanol sclerotherapy, for bleeding cessation from internal hemorrhoids in cirrhotic patients.
Aim and Objective - To compare flexible endoscopic polidocanol liquid and foam sclerotherapy in cirrhotic patients with bleeding from internal hemorrhoids
Primary objective: No recurrence of hemorrhoidal bleeding episodes at 1-week after endotherapy
Secondary objectives:
- Ano-rectal bleeding at 4-wks, defined by Giamundo score. [Ordinal score 0-4]
- Ano-rectal bleeding at 8-wks, defined by Giamundo score. [Ordinal score 0-4]
- Proportion of patients requiring a 2nd treatment session within 8-wks. [Indications: Giamundo score >3, or hemoglobin drop >1g/dL, or requirement of transfusion, or clinician discretion; Time frame: 8-weeks]
- Proportion of patients with failed endotherapy. [Persistent bleeding with Giamundo score >3 from internal hemorrhoids or treatment related ulcers, after 2nd endotherapy session; Time frame: 8-weeks]
- Proportion of patients requiring BT for hemorrhoidal bleeding within 8 wks.
- Relationship of MELD score (4-40) with no recurrence of bleeding at 7d.
- Adverse events/ local infectious complications after endotherapy. [Time frame: 8-wks]
- Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal varices and/or portal colopathy.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic/ACLF patients with ano-rectal bleeding, either ongoing or within last 1-week, judged to be hemorrhoidal in origin based on clinical features and endoscopy evaluation.
排除标准
- •Coagulopathy threshold of INR >2.0 and/or platelet count <50,000/mm
- •Antiplatelet or anticoagulants use.
- •Immunosuppressive medications (including steroids >20mg/d or equivalent for >2 weeks).
- •Grade IV internal hemorrhoids.
- •Thrombosed or strangulated IH or EH.
- •Previous EST or RBL in last 1-year.
- •Co-existing ano-rectal diseases like perianal abscess, stricture, fistula, anal malignancies, ano-rectal stenosis, radiation proctitis, or proctitis.
- •Patients not capable of understanding and signing the informed consent.
- •Bronchial Asthma.
结局指标
主要结局
Proportion of patients with no recurrence of hemorrhoidal bleeding episodes at 1 week after endotherapy.
时间窗: 1 week
次要结局
- Adverse events/ local infectious complications after endotherapy.(8 weeks)
- Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal varices and/or portal colopathy.(8 weeks)
- Relationship of Model for end stage liver disease (MELD) score with no recurrence of bleeding at 7 days [ Minimum 4 to maximum 40; Higher meaning worse.(7 days)
- Number of participants with ano-rectal bleeding at 4 weeks, defined by giamundos core [ Ordinal score from 0-4 ; Higher score meaning worse outcome(4 weeks)
- Number of participants with ano-rectal bleeding at 8 weeks, defined by giamundos core [ Ordinal score from 0-4 ; Higher score meaning worse outcome(8 weeks)
- Proportion of patients requiring a 2nd treatment session within 8 weeks(8 weeks)
- Proportion of patients with failed endotherapy.(8 weeks)
- Proportion of patients requiring BT for hemorrhoidal bleeding within 8 weeks.(8 weeks)