Comparison of Endoscopic Needle-Knife Stricturotomy Versus Endoscopic Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease: A Multicenter, Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Percentage of Treated Small Bowel Strictures With Procedure-Related Bleeding or Perforation
研究概览
简要总结
This multicenter, open-label, randomized controlled trial aims to compare the safety and immediate effectiveness of endoscopic stricturotomy (ES) and endoscopic balloon dilation (EBD) for the treatment of small bowel fibrotic strictures in patients with Crohn's disease.
Eligible participants with Crohn's disease and small bowel fibrotic strictures will be randomly assigned to receive either endoscopic stricturotomy or endoscopic balloon dilation. The study will compare procedure-related bleeding or perforation between the two treatment groups and will also evaluate immediate technical success, defined by whether the enteroscope can pass through the treated stricture after the procedure.
The study is intended to provide clinical evidence on the safety and feasibility of endoscopic stricturotomy as an endoscopic treatment option for small bowel fibrotic strictures in Crohn's disease.
详细描述
Fibrotic intestinal strictures are an important complication of Crohn's disease. Medical therapy can effectively control intestinal inflammation, but established fibrotic strictures may respond poorly to medical treatment and may require endoscopic or surgical intervention. Endoscopic balloon dilation is commonly used for selected Crohn's disease-related strictures, but limitations include recurrence and the potential need for repeated procedures or surgery. Endoscopic stricturotomy is an alternative endoscopic approach that directly incises the fibrotic stricture and may provide another treatment option for patients with Crohn's disease-related small bowel strictures.
This study is a multicenter, open-label, randomized, parallel-group controlled trial comparing endoscopic stricturotomy with endoscopic balloon dilation in patients with Crohn's disease and small bowel fibrotic strictures. Participants who meet the eligibility criteria will be randomly allocated to one of the two endoscopic treatment groups.
In the endoscopic stricturotomy group, the fibrotic stricture will be incised endoscopically until adequate luminal enlargement is achieved. In the endoscopic balloon dilation group, the stricture will be dilated endoscopically using a dilation balloon. After treatment, the treated stricture will be reassessed endoscopically.
The study primarily aims to compare the safety of the two endoscopic approaches and secondarily to compare their immediate technical effectiveness.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years.
- •Diagnosis of Crohn's disease for at least 3 months before screening, based on clinical manifestations and endoscopic and/or imaging findings, with histopathological support.
- •Presence of a small bowel stricture that prevents passage of the enteroscope.
- •Partial intestinal obstruction, meeting the following criteria:
- •Clinical manifestations of partial intestinal obstruction;
- •Small bowel stricture identified by endoscopy (with a lumen narrower than the distal end of the enteroscope) or computed tomography enterography (CTE); and
- •Marked dilation of the bowel lumen proximal to the stricture demonstrated by enteroscopy or CTE.
- •Written informed consent and any required privacy authorization signed and dated by the participant or the participant's legally authorized representative, as applicable, before initiation of study procedures.
- •Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use adequate conventional contraception throughout the study period, beginning at the time of signing the informed consent form.
排除标准
- •Anastomotic stricture.
- •Deep or large ulceration at the stricture site.
- •Marked angulation or sharp bending at the stricture site.
- •An absolute indication for surgical treatment, including acute perforation, major bleeding that cannot be managed medically or endoscopically, intra-abdominal abscess, small bowel fistula, or malignancy.
- •Inability to tolerate anesthesia, enteroscopy, or surgical treatment because of conditions such as cardiac or pulmonary failure or severe coagulation disorders.
- •Evidence of active infection during the screening period.
- •Active tuberculosis, including findings suspicious for pulmonary tuberculosis on chest radiography performed within 3 months before Week
- •Any confirmed congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection or organ transplantation.
- •A clinically significant infection, such as pneumonia or pyelonephritis, within 30 days before screening, or an ongoing chronic infection.
- •Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematologic, coagulation, immune, endocrine/metabolic, or other medical condition that, in the investigator's opinion, could interfere with study results or compromise participant safety.
- •History of malignancy.
- •Any of the following laboratory abnormalities during screening:
- •Hemoglobin <5 g/dL;
- •White blood cell count <3 × 10^9/L;
- •Platelet count <100 × 10^9/L or >1200 × 10^9/L;
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN); or
- •Serum creatinine >2 times the ULN.
- •Inability to attend all required study visits or comply with study procedures.
- •Female participants who are pregnant, plan to become pregnant before or during study participation, or plan to donate ova during this period.
- •Participants who are coerced into consenting to study participation.
- •Any other condition that, in the investigator's opinion, makes the participant unsuitable for endoscopic or surgical treatment.
研究组 & 干预措施
Endoscopic Stricturotomy
Participants assigned to this arm will undergo endoscopic stricturotomy for Crohn's disease-related small bowel fibrotic strictures. The stricture will be incised endoscopically until adequate luminal enlargement is achieved, followed by endoscopic reassessment of the treated stricture.
干预措施: Endoscopic Stricturotomy (Procedure)
Endoscopic Balloon Dilation
Participants assigned to this arm will undergo endoscopic balloon dilation for Crohn's disease-related small bowel fibrotic strictures. The stricture will be dilated endoscopically using a dilation balloon, followed by endoscopic reassessment of the treated stricture.
干预措施: Endoscopic Balloon Dilation (Procedure)
结局指标
主要结局
Percentage of Treated Small Bowel Strictures With Procedure-Related Bleeding or Perforation
时间窗: During and immediately after the endoscopic procedure
The primary outcome is the percentage of treated small bowel strictures with procedure-related bleeding or perforation after endoscopic stricturotomy or endoscopic balloon dilation. The percentage will be calculated as the number of treated strictures with bleeding or perforation divided by the total number of treated strictures, multiplied by 100.
次要结局
- Percentage of Treated Small Bowel Strictures With Technical Success(Immediately after the endoscopic procedure)