An interventional study of Endoscopic Stricturotomy and Endoscopic Balloon Dilation in Crohn Disease (CD), Intestinal Stricture and Intestinal Fibrosis, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Treatment
Among 34 studies in Crohn Disease by Sixth Affiliated Hospital, Sun Yat-sen University — 14 open to participants now, 14 under way, none of them phase 3. Crohn Disease · Sixth Affiliated Hospital, Sun Yat-sen University.
Among the 34 studies in Crohn Disease by Sixth Affiliated Hospital, Sun Yat-sen University, this one is the 3rd largest by planned enrollment of the 20 interventional ones that give a count, is one of 3 that started in 2024, is one of 10 with no phase, reaches primary completion later than 8 of the 13 other live ones, and was the 34th registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
Browse Crohn Disease studies →14 of the 34 studies in Crohn Disease by Sixth Affiliated Hospital, Sun Yat-sen University are open now, in 1 country. Recruiting first, the newest first:
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
By country, each count listing its studies:
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 4 · Phase 4 5
First in 2010; this study’s year is marked. 3 started in 2024.
This study's planned enrollment of 244 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Median enrollment 150 across the 20 interventional studies, 275 across the 14 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.
4 of the studies in Crohn Disease by Sixth Affiliated Hospital, Sun Yat-sen University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07504510Sixth Affiliated Hospital, Sun Yat-sen UniversityExclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease | 2026-12-31 |
| NCT06520397Sixth Affiliated Hospital, Sun Yat-sen UniversityEfficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease | 2026-12-31 |
| NCT06165289Sixth Affiliated Hospital, Sun Yat-sen UniversityEndoscopic Balloon Dilatation Combined With PRP Injection in Colonic Stenosis in Crohn's Disease | 2026-12-31 |
| NCT07545317Sixth Affiliated Hospital, Sun Yat-sen UniversityReal-World Study of IL-23 Inhibitors in Active Crohn's Disease | 2027-08-31 |
Among the 34 studies in Crohn Disease by Sixth Affiliated Hospital, Sun Yat-sen University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Partial intestinal obstruction, meeting the following criteria:
Exclusion Criteria:
Any of the following laboratory abnormalities during screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Endoscopic Stricturotomy
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.
Procedure: Endoscopic Balloon Dilation
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.
Also known as: ES
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.
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.
Time frame: During and immediately after the endoscopic procedure
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.
Time frame: Immediately after the endoscopic procedure
Crohn's Disease Obstructive Score (CDOS)
The Crohn's Disease Obstructive Score (CDOS) is used to assess the severity of obstructive symptoms in patients with Crohn's disease. The score includes six components related to obstructive abdominal pain, nausea or vomiting, dietary restriction, and hospitalization. The total score ranges from 0 to 6, with higher scores indicating more severe obstructive symptoms.
Time frame: 1 year
Crohn's Disease Activity Index (CDAI)
The Crohn's Disease Activity Index (CDAI) is used to assess Crohn's disease activity based on eight clinical variables. A CDAI score below 150 indicates clinical remission; scores of 150-220, 221-450, and above 450 indicate mild, moderate, and severe disease activity, respectively.
Time frame: 1 year
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item disease-specific questionnaire used to assess health-related quality of life. The total score ranges from 32 to 224, with higher scores indicating better health-related quality of life.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Dec 2027, 46 months after the start.
Of 287 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 46 months is close to that.
Counting every sponsor, half of 299 studies reached it within 45 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Sixth Affiliated Hospital, Sun Yat-sen University →