Crohn Disease (CD)HEISTNCT06958159
Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Stricturotomy Alone for Short Crohn's Disease Strictures
A study testing Endoscopic Stricturotomy and Endoscopic Balloon Dilation in people with Crohn Disease (CD), run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Crohn's disease is a chronic condition that can lead to inflammation and narrowing (strictures) of the intestine, causing symptoms like pain, bloating, and difficulty with bowel movements. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease (CD)
- 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
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 29 Apr 2025to 15 May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Diagnosed Crohn's disease based on clinical, endoscopic, histologic, or radiologic criteria.
- Presence of fibrotic or mixed strictures measuring less than 3 cm in length.
- A maximum of two strictures per patient.
- Strictures located in endoscopically accessible sites
Who cannot join
- Predominantly ulcerated or active inflammatory strictures.
- Strictures longer than 3 cm.
- Strictures not accessible via standard colonoscopy.
- Pregnancy.
- Three or more strictures identified in a single patient.
- Prior endoscopic stricturotomy at the same stricture site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
Duvvuru Nageshwar Reddy, MD, DM, MASGE, FACG, AGAF, +91-40-23378888, aigindia@yahoo.co.in
About this study
Official title: Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures (<3 cm) in Crohn's Disease (The HEIST Study)
Crohn's disease is a chronic condition that can lead to inflammation and narrowing (strictures) of the intestine, causing symptoms like pain, bloating, and difficulty with bowel movements. These strictures are often treated with endoscopic procedures such as balloon dilation or stricturotomy to widen the narrowed segments and relieve symptoms.
The HEIST Study is a randomized clinical trial designed to compare two endoscopic treatment strategies for short Crohn's disease-related strictures (less than 3 centimeters in length). One group will undergo endoscopic stricturotomy alone, while the other group will receive a combination of stricturotomy followed by balloon dilation (hybrid approach).
Read more
The goal is to determine whether the hybrid approach improves long-term outcomes such as symptom relief, reduced need for repeat procedures, and avoidance of surgery. Patients will be followed for 12 months after treatment to assess durability of response, quality of life, and any complications or additional interventions needed.
This study aims to provide high-quality evidence to guide endoscopic treatment of intestinal strictures in Crohn's disease and to help identify the most effective and safest approach for long-term symptom control.
Read the detailed description
The HEIST Study (Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures in Crohn's Disease) is a prospective, randomized controlled trial designed to compare two endoscopic treatment strategies for short, fibrotic strictures in patients with Crohn's disease. The trial specifically evaluates whether the addition of balloon dilation to endoscopic stricturotomy improves clinical outcomes compared to stricturotomy alone.
Eligible patients will have symptomatic, non-angulated strictures less than 3 centimeters in length, located in the colon or neo-terminal ileum. Participants will be randomly assigned during colonoscopy to receive either (1) endoscopic stricturotomy alone or (2) endoscopic stricturotomy followed by balloon dilation using a controlled radial expansion balloon (up to 18 mm diameter). Interventions will be performed using a therapeutic colonoscope and either a needle knife or insulated-tip knife, followed by balloon inflation if applicable.
All procedures will be carried out by experienced interventional endoscopists using a standardized protocol. Patients will be evaluated at baseline, immediately post-procedure, and at 1, 3, 6, and 12 months following the intervention. The follow-up includes clinical symptom scoring using the Crohn's Disease Obstructive Symptom Score, adverse event monitoring, quality of life assessment, and documentation of any further endoscopic or surgical intervention.
The primary outcome is the rate of clinical success at 12 months, defined as sustained symptom improvement without the need for repeat endoscopic or surgical intervention. Secondary outcomes include technical success, rate of complications (e.g., bleeding, perforation), time to re-intervention, and changes in quality of life metrics.
By evaluating these two commonly used endoscopic techniques in a randomized design with 12-month follow-up, the HEIST Study aims to provide evidence to optimize endoscopic treatment of short strictures in Crohn's disease and support treatment decisions in routine clinical practice.
- Conditions
- Crohn Disease (CD)
- Being tested
- Endoscopic Stricturotomy, Endoscopic Balloon Dilation
- Keywords
- Endoscopic balloon dilation, Endoscopic stricturotomy, Crohn disease, re-intervention
- 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
Endoscopic stricturotomy is performed using either a needle knife or an insulated-tip (IT) knife (Olympus, Tokyo, Japan), selected based on the location and morphology of the stricture. Electrosurgical cutting is delivered using the Endo Cut I mode on an ERBE VIO 300D or VIO 3 electrosurgical unit (Erbe Elektromedizin, Germany), with standardized settings: Effect 3, Cut Duration 1, Cut Interval 3.
Radial incisions are initially made across the stricture, followed by circumferential cutting in non-ulcerated areas to relieve luminal narrowing. The goal is to achieve adequate stricture opening while minimizing the risk of perforation.
Endoscopic Balloon DilationProcedure or surgery
Endoscopic balloon dilation is performed using a Controlled Radial Expansion (CRE) balloon (Boston Scientific, USA). The size of the balloon is selected based on the estimated diameter of the stricture, presence or absence of ulceration, and the anatomical location.
The balloon is gradually inflated under endoscopic visualization to a maximum diameter of 12-20 mm, tailored to the baseline luminal narrowing. The balloon is maintained at full inflation for 60 seconds to achieve controlled and uniform dilation of the stricture.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Stricturotomy Alone | Experimental | Participants in this arm will undergo endoscopic stricturotomy alone for the treatment of short (<3 cm), fibrotic, symptomatic Crohn's disease strictures. The procedure will be performed using a needle knife or insulated-tip knife during colonoscopy, following a standardized protocol. Receives: Procedure: Endoscopic Stricturotomy |
| Hybrid Endoscopic Stricturotomy Plus Balloon Dilation | Experimental | Participants in this arm will undergo hybrid therapy consisting of endoscopic stricturotomy followed by controlled radial expansion balloon dilation of the stricture during the same session. The procedure is intended to enhance luminal patency and reduce the risk of recurrence. Receives: Procedure: Endoscopic Stricturotomy; Procedure: Endoscopic Balloon Dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Recurrence Within 12 Months
Clinical recurrence is defined as a Crohn's Disease Obstruction Score (CDOS) >2 following an initial clinical response. Initial response is defined as a ≥2-point reduction in CDOS or normalization to CDOS ≤2. Time to recurrence is measured from the date of the procedure to the first recurrence event. Participants without recurrence will be censored at their last follow-up or at 12 months.
Measured: Up to 12 months post-procedure
Secondary outcomes (7)
Technical Success
Technical success is defined as the ability to pass a pediatric colonoscope beyond the treated stricture during the same session as the endoscopic procedure.
Measured: Day of procedure
Clinical Response
Clinical response is defined as a reduction in CD Obstruction Score (CDOS) by ≥2 points from baseline, or normalization of the CDOS to ≤2, measured at 1 month after the intervention.
Measured: 1 month post-procedure
Time to Re-intervention
Time (in days) from the index procedure to the first repeat endoscopic intervention (balloon dilation or stricturotomy or hybrid) for the same stricture. Participants without re-intervention will be censored at last follow-up or at 12 months
Measured: Up to 12 months post-procedure
Time to Intestinal Surgery
Time from the index endoscopic procedure to intestinal surgery related to the treated stricture. Participants who do not undergo surgery will be censored at the last follow-up or 12 months.
Measured: Up to 12 months post-procedure
Time to Stricture-Related Hospitalization
Time from the index procedure to first hospitalization caused by stricture-related complications or obstructive symptoms. Participants without hospitalization will be censored at last follow-up or 12 months.
Measured: Up to 12 months post-procedure
Time to Stricture-Related Emergency Department Visit
Time from the index endoscopic procedure to the first emergency department visit related to stricture-associated symptoms. Participants without an emergency visit will be censored at last follow-up or 12 months.
Measured: Up to 12 months post-procedure
Adverse events
Number and type of adverse events (e.g., bleeding, perforation, post-procedure pain, infection) occurring during or within 30 days of the endoscopic procedure.
Measured: Up to 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start29 Apr 2025
- Primary completion15 Mar 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958159
- Sponsor's protocol ID
- AIG/IEC-BH&R 65/12.2024-04
- Acronym
- HEIST
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center, investigator-initiated trial without a formal data-sharing infrastructure. De-identification and secure long-term storage mechanisms are not currently available for external data distribution. Summary-level data will be published in peer-reviewed journals.
Publications
Lan N, Shen B. Endoscopic Stricturotomy Versus Balloon Dilation in the Treatment of Anastomotic Strictures in Crohn's Disease. Inflamm Bowel Dis. 2018 Mar 19;24(4):897-907. doi: 10.1093/ibd/izx085.
PubMed 29546384
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures (<3 cm) in Crohn's Disease (The HEIST Study)
- ClinicalTrials.gov ID
- NCT06958159
- Acronym / sponsor ID
- HEIST / AIG/IEC-BH&R 65/12.2024-04
- Conditions
- Crohn Disease (CD)
- Keywords
- Endoscopic balloon dilation, Endoscopic stricturotomy, Crohn disease, re-intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 6 May 2025 (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.
Crohn's disease is a chronic condition that can lead to inflammation and narrowing (strictures) of the intestine, causing symptoms like pain, bloating, and difficulty with bowel movements. These strictures are often treated with endoscopic procedures such as balloon dilation or stricturotomy to widen the narrowed segments and relieve symptoms.
The HEIST Study is a randomized clinical trial designed to compare two endoscopic treatment strategies for short Crohn's disease-related strictures (less than 3 centimeters in length). One group will undergo endoscopic stricturotomy alone, while the other group will receive a combination of stricturotomy followed by balloon dilation (hybrid approach).
The goal is to determine whether the hybrid approach improves long-term outcomes such as symptom relief, reduced need for repeat procedures, and avoidance of surgery. Patients will be followed for 12 months after treatment to assess durability of response, quality of life, and any complications or additional interventions needed.
This study aims to provide high-quality evidence to guide endoscopic treatment of intestinal strictures in Crohn's disease and to help identify the most effective and safest approach for long-term symptom control.
Detailed description
The HEIST Study (Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures in Crohn's Disease) is a prospective, randomized controlled trial designed to compare two endoscopic treatment strategies for short, fibrotic strictures in patients with Crohn's disease. The trial specifically evaluates whether the addition of balloon dilation to endoscopic stricturotomy improves clinical outcomes compared to stricturotomy alone.
Eligible patients will have symptomatic, non-angulated strictures less than 3 centimeters in length, located in the colon or neo-terminal ileum. Participants will be randomly assigned during colonoscopy to receive either (1) endoscopic stricturotomy alone or (2) endoscopic stricturotomy followed by balloon dilation using a controlled radial expansion balloon (up to 18 mm diameter). Interventions will be performed using a therapeutic colonoscope and either a needle knife or insulated-tip knife, followed by balloon inflation if applicable.
All procedures will be carried out by experienced interventional endoscopists using a standardized protocol. Patients will be evaluated at baseline, immediately post-procedure, and at 1, 3, 6, and 12 months following the intervention. The follow-up includes clinical symptom scoring using the Crohn's Disease Obstructive Symptom Score, adverse event monitoring, quality of life assessment, and documentation of any further endoscopic or surgical intervention.
The primary outcome is the rate of clinical success at 12 months, defined as sustained symptom improvement without the need for repeat endoscopic or surgical intervention. Secondary outcomes include technical success, rate of complications (e.g., bleeding, perforation), time to re-intervention, and changes in quality of life metrics.
By evaluating these two commonly used endoscopic techniques in a randomized design with 12-month follow-up, the HEIST Study aims to provide evidence to optimize endoscopic treatment of short strictures in Crohn's disease and support treatment decisions in routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Stricturotomy Alone | Experimental | Procedure: Endoscopic StricturotomyParticipants in this arm will undergo endoscopic stricturotomy alone for the treatment of short (<3 cm), fibrotic, symptomatic Crohn's disease strictures. The procedure will be performed using a needle knife or insulated-tip knife during colonoscopy, following a standardized protocol. |
| Hybrid Endoscopic Stricturotomy Plus Balloon Dilation | Experimental | Procedure: Endoscopic Stricturotomy, Procedure: Endoscopic Balloon DilationParticipants in this arm will undergo hybrid therapy consisting of endoscopic stricturotomy followed by controlled radial expansion balloon dilation of the stricture during the same session. The procedure is intended to enhance luminal patency and reduce the risk of recurrence. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years.
- Diagnosed Crohn's disease based on clinical, endoscopic, histologic, or radiologic criteria.
- Presence of fibrotic or mixed strictures measuring less than 3 cm in length.
- A maximum of two strictures per patient.
- Strictures located in endoscopically accessible sites
Key exclusion criteria (6 listed)
- Predominantly ulcerated or active inflammatory strictures.
- Strictures longer than 3 cm.
- Strictures not accessible via standard colonoscopy.
- Pregnancy.
- Three or more strictures identified in a single patient.
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 StricturotomyEndoscopic stricturotomy is performed using either a needle knife or an insulated-tip (IT) knife (Olympus, Tokyo, Japan), selected based on the location and morphology of the stricture. Electrosurgical cutting is delivered using the Endo Cut I mode on an ERBE VIO 300D or VIO 3 electrosurgical unit (Erbe Elektromedizin, Germany), with standardized settings: Effect 3, Cut Duration 1, Cut Interval 3. Radial incisions are initially made across the stricture, followed by circumferential cutting in non-ulcerated areas to relieve luminal narrowing. The goal is to achieve adequate stricture opening while minimizing the risk of perforation. | Procedure or surgery | Endoscopic Stricturotomy Alone, Hybrid Endoscopic Stricturotomy Plus Balloon Dilation |
| Endoscopic Balloon DilationEndoscopic balloon dilation is performed using a Controlled Radial Expansion (CRE) balloon (Boston Scientific, USA). The size of the balloon is selected based on the estimated diameter of the stricture, presence or absence of ulceration, and the anatomical location. The balloon is gradually inflated under endoscopic visualization to a maximum diameter of 12-20 mm, tailored to the baseline luminal narrowing. The balloon is maintained at full inflation for 60 seconds to achieve controlled and uniform dilation of the stricture. | Procedure or surgery | Hybrid Endoscopic Stricturotomy Plus Balloon Dilation |
Primary outcome
Time to Clinical Recurrence Within 12 Months
Time frame: Up to 12 months post-procedure
Clinical recurrence is defined as a Crohn's Disease Obstruction Score (CDOS) >2 following an initial clinical response. Initial response is defined as a ≥2-point reduction in CDOS or normalization to CDOS ≤2. Time to recurrence is measured from the date of the procedure to the first recurrence event. Participants without recurrence will be censored at their last follow-up or at 12 months.
7 secondary outcomes
Technical Success
Time frame: Day of procedure
Clinical Response
Time frame: 1 month post-procedure
Time to Re-intervention
Time frame: Up to 12 months post-procedure
Time to Intestinal Surgery
Time frame: Up to 12 months post-procedure
Time to Stricture-Related Hospitalization
Time frame: Up to 12 months post-procedure
Time to Stricture-Related Emergency Department Visit
Time frame: Up to 12 months post-procedure
Adverse events
Time frame: Up to 30 days post-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 17 Jul 2025.
- Background: PubMed 29546384Lan N, Shen B. Endoscopic Stricturotomy Versus Balloon Dilation in the Treatment of Anastomotic Strictures in Crohn's Disease. Inflamm Bowel Dis. 2018 Mar 19;24(4):897-907. doi: 10.1093/ibd/izx085.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center, investigator-initiated trial without a formal data-sharing infrastructure. De-identification and secure long-term storage mechanisms are not currently available for external data distribution. Summary-level data will be published in peer-reviewed journals.
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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), run by Asian Institute of Gastroenterology, India at 1 site in India.
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 5 inclusion and 6 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 17 Jul 2025. 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 India. 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 Partha Pal, MD, DNB, MRCP (UK), FASGE (+91-8945906823, partha0123456789@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Recurrence Within 12 Months (time frame: Up to 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958159, which also lists 1 linked publication.
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 17 Jul 2025.