Crohn Disease (CD)NCT07833332
Endoscopic Stricturotomy Versus Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease
A study testing Endoscopic Stricturotomy and Endoscopic Balloon Dilation in people with Crohn Disease (CD) and Intestinal Stricture, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease (CD), Intestinal Stricture, Intestinal Fibrosis
- What is being tested?
- Endoscopic Stricturotomy and Endoscopic Balloon Dilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Qin Guo, MD, +86-13507406889, guoq83@mail.sysu.edu.cn
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Endoscopic Stricturotomy, Endoscopic Balloon Dilation
- Keywords
- Endoscopic Stricturotomy, Endoscopic Balloon Dilation, Small Bowel Stricture, Fibrotic Stricture, Balloon-Assisted Enteroscopy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic StricturotomyProcedure or surgery
Also called ES
Endoscopic stricturotomy is performed for the small bowel fibrotic stricture using an endoscopic incision knife. The stricture is incised in a partial or circumferential manner until adequate luminal enlargement is achieved. Hemostasis is performed if necessary, and the treated stricture is reassessed endoscopically after the procedure.
Endoscopic Balloon DilationProcedure or surgery
Endoscopic balloon dilation is performed for the small bowel fibrotic stricture using a dilation balloon introduced over a guidewire. The stricture is dilated endoscopically and reassessed after the procedure to determine whether the enteroscope can pass through the treated stricture.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Stricturotomy | Experimental | 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. Receives: Procedure: Endoscopic Stricturotomy |
| Endoscopic Balloon Dilation | Active comparator | 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. Receives: Procedure: Endoscopic Balloon Dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treated Small Bowel Strictures With Procedure-Related Bleeding or Perforation
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.
Measured: During and immediately after the endoscopic procedure
Secondary outcomes (1)
Percentage of Treated Small Bowel Strictures With Technical Success
Technical success is defined as successful passage of the enteroscope through the treated small bowel stricture after endoscopic stricturotomy or endoscopic balloon dilation. The percentage will be calculated as the number of treated strictures through which the enteroscope can successfully pass divided by the total number of treated strictures, multiplied by 100.
Measured: Immediately after the endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start18 Feb 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to endoscopic stricturotomy or endoscopic balloon dilation in a multicenter, open-label, parallel-group trial.
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sir Run Run Shaw Hospital, Air Force Military Medical University, China, Second Xiangya Hospital of Central South University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833332
- Sponsor's protocol ID
- 1010CG(2023)-02
- Other IDs
- 2024ZSLYEC-054
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07833332
- Acronym / sponsor ID
- 1010CG(2023)-02
- Keywords
- Endoscopic Stricturotomy, Endoscopic Balloon Dilation, Small Bowel Stricture, Fibrotic Stricture, Balloon-Assisted Enteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sir Run Run Shaw Hospital, Air Force Military Medical University, China, Second Xiangya Hospital of Central South University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to endoscopic stricturotomy or endoscopic balloon dilation in a multicenter, open-label, parallel-group trial.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Stricturotomy | Experimental | Procedure: Endoscopic StricturotomyParticipants 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. |
| Endoscopic Balloon Dilation | Active comparator | Procedure: Endoscopic Balloon DilationParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic StricturotomyAlso: ESEndoscopic stricturotomy is performed for the small bowel fibrotic stricture using an endoscopic incision knife. The stricture is incised in a partial or circumferential manner until adequate luminal enlargement is achieved. Hemostasis is performed if necessary, and the treated stricture is reassessed endoscopically after the procedure. | Procedure or surgery | Endoscopic Stricturotomy |
| Endoscopic Balloon DilationEndoscopic balloon dilation is performed for the small bowel fibrotic stricture using a dilation balloon introduced over a guidewire. The stricture is dilated endoscopically and reassessed after the procedure to determine whether the enteroscope can pass through the treated stricture. | Procedure or surgery | Endoscopic Balloon Dilation |
Primary outcome
Percentage of Treated Small Bowel Strictures With Procedure-Related Bleeding or Perforation
Time frame: 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.
1 secondary outcome
Percentage of Treated Small Bowel Strictures With Technical Success
Time frame: Immediately after the endoscopic procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Stricturotomy and Endoscopic Balloon Dilation in people with Crohn Disease (CD) and Intestinal Stricture, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qin Guo, MD (+86-13507406889, guoq83@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Treated Small Bowel Strictures With Procedure-Related Bleeding or Perforation (time frame: During and immediately after the endoscopic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.