Crohn Disease study: Endoscopic Stricturotomy vs Endoscopic Balloon Dilation
Official title Endoscopic Stricturotomy Versus Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease
ClinicalTrials.gov ID: NCT07833332
What this study is testing
- What it's testing
- The study will see which procedure, endoscopic stricturotomy or balloon dilation, is safer and works better right after the treatment.
- Who it's for
- People with Crohn’s disease who have fibrotic strictures in the small intestine.
- What's involved
- Participants will be randomly given one of the two procedures. Doctors will check for bleeding, perforation, and whether the scope can pass through the stricture afterward.
- Time commitment
- The study lasts only for the procedure and the immediate follow‑up after it; no long‑term visits are required.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Presence of a small bowel stricture that prevents passage of the enteroscope.
- 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...
You likely can't join if
- 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...
- Inability to tolerate anesthesia, enteroscopy, or surgical treatment because of conditions such as cardiac or pulmonary failure or severe coagulation...
- Evidence of active infection during the screening period.
See the full eligibility criteria
- 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.
- 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...
- 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 0.
- 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...
- History of malignancy.
- Hemoglobin \<5 g/dL;
- White blood cell count \<3 × 10\^9/L;
- Platelet count \ 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Guangzhou, Guangdong, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.