Esophageal StrictureNCT04372784
Cryoablation for Benign Gastrointestinal Anastomotic Strictures
A study testing Cryotherapy and Esophagogastroduodenoscopy with Balloon Dilatation in people with Esophageal Stricture and Duodenal Stricture, run by University of Southern California at 1 site in United States.
Trial summary
Anastomotic stricture is a common complication following foregut surgery. The standard of care for these benign foregut anastomotic strictures is balloon dilatation. However, re-stenosis of strictures is also common, requiring frequent repetition of balloon dilatation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Stricture, Duodenal Stricture, Jejunal Stricture
- What is being tested?
- Cryotherapy and Esophagogastroduodenoscopy with Balloon Dilatation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of esophagectomywith primary anastomosis
- History of gastrectomy with primary anastomosis
- History of bariatric surgery with primary anastomosis
- History of anastomotic stricture
- History of balloon dilatation at Keck Hospital of the University of Southern California
Who cannot join
- Patients treated at medical centers other than Keck Hospital of the University of Southern California
- History of anastomotic stent placement
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck Hospital of USC
Los Angeles, California, 90033
Kulmeet Sandhu, MD, 323-442-5831, kulmeet.sandhu@med.usc.edu
About this study
Official title: A Randomized Controlled Trial of Cryotherapy on Benign Anastomotic Strictures Following Esophagectomy, Gastrectomy, and Bariatric Surgery
Anastomotic stricture is a common complication following foregut surgery. The standard of care for these benign foregut anastomotic strictures is balloon dilatation. However, re-stenosis of strictures is also common, requiring frequent repetition of balloon dilatation. Cryotherapy is a novel therapy that may improve clinical outcomes following dilatation. The purpose of the present study is to conduct a randomized controlled trial to characterize the impact of cryotherapy on clinical outcomes and complications for benign anastomotic strictures following esophagectomy, gastrectomy, and bariatric surgery.
- Conditions
- Esophageal Stricture, Duodenal Stricture, Jejunal Stricture, Anastomotic Stricture of Small Intestine
- Being tested
- Cryotherapy, Esophagogastroduodenoscopy with Balloon Dilatation
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
Cryotherapy entails introducing a 9 French catheter via the endoscope's accessory port. The catheter is advanced until it is visualized on the endoscopy monitor. Under 4 psi pressure, liquid nitrogen is sprayed from the catheter for twenty seconds over each four-centimeter segment of stricture
Esophagogastroduodenoscopy with Balloon DilatationProcedure or surgery
This procedure entails deploying a balloon via the accessory port of the esophagogastroduodenoscope under direct visualization and serially inflating the balloon. Balloon dilatation disrupts not only the muscular rings surrounding strictures but also the granulation tissue composing the strictures.
| Study group | Role | What they receive |
|---|---|---|
| EGD with Balloon Dilatation | Active comparator | Esophagogastroduodenoscopy with balloon dilatation Receives: Procedure: Esophagogastroduodenoscopy with Balloon Dilatation |
| EGD with Balloon Dilatation and Cryotherapy | Experimental | Esophagogastroduodenoscopy with balloon dilatation and cryotherapy Receives: Device: Cryotherapy; Procedure: Esophagogastroduodenoscopy with Balloon Dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dilatations
Total number of dilations within one year
Measured: One year
Secondary outcomes (6)
Dilatation size
Dilatation size (as a proportion to size at presentation)
Measured: Immediately after the intervention/procedure/surgery/etc
Perforation rate
Rates of hollow viscus perforation
Measured: Immediately after the intervention/procedure/surgery/etc
Bleeding rate
Rates of clinically significant bleeding
Measured: Immediately after the intervention/procedure/surgery/etc
Fistula rate
Rates of fistula formation
Measured: One year
Reintervention
Rates of unplanned reintervention (e.g., stenting)
Measured: One year
Readmission
Rates of readmission
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study startSep 2020 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StrictureStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kulmeet Sandhu, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372784
- Sponsor's protocol ID
- HS-19-00679
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cryotherapy on Benign Anastomotic Strictures Following Esophagectomy, Gastrectomy, and Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04372784
- Acronym / sponsor ID
- HS-19-00679
- Conditions
- Esophageal Stricture, Duodenal Stricture, Jejunal Stricture, Anastomotic Stricture of Small Intestine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 May 2020 (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.
Anastomotic stricture is a common complication following foregut surgery. The standard of care for these benign foregut anastomotic strictures is balloon dilatation. However, re-stenosis of strictures is also common, requiring frequent repetition of balloon dilatation. Cryotherapy is a novel therapy that may improve clinical outcomes following dilatation. The purpose of the present study is to conduct a randomized controlled trial to characterize the impact of cryotherapy on clinical outcomes and complications for benign anastomotic strictures following esophagectomy, gastrectomy, and bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGD with Balloon Dilatation | Active comparator | Procedure: Esophagogastroduodenoscopy with Balloon DilatationEsophagogastroduodenoscopy with balloon dilatation |
| EGD with Balloon Dilatation and Cryotherapy | Experimental | Device: Cryotherapy, Procedure: Esophagogastroduodenoscopy with Balloon DilatationEsophagogastroduodenoscopy with balloon dilatation and cryotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of esophagectomywith primary anastomosis
- History of gastrectomy with primary anastomosis
- History of bariatric surgery with primary anastomosis
- History of anastomotic stricture
- History of balloon dilatation at Keck Hospital of the University of Southern California
Key exclusion criteria (2 listed)
- Patients treated at medical centers other than Keck Hospital of the University of Southern California
- History of anastomotic stent placement
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 |
|---|---|---|
| CryotherapyCryotherapy entails introducing a 9 French catheter via the endoscope's accessory port. The catheter is advanced until it is visualized on the endoscopy monitor. Under 4 psi pressure, liquid nitrogen is sprayed from the catheter for twenty seconds over each four-centimeter segment of stricture | Device | EGD with Balloon Dilatation and Cryotherapy |
| Esophagogastroduodenoscopy with Balloon DilatationThis procedure entails deploying a balloon via the accessory port of the esophagogastroduodenoscope under direct visualization and serially inflating the balloon. Balloon dilatation disrupts not only the muscular rings surrounding strictures but also the granulation tissue composing the strictures. | Procedure or surgery | EGD with Balloon Dilatation, EGD with Balloon Dilatation and Cryotherapy |
Primary outcome
Number of Dilatations
Time frame: One year
Total number of dilations within one year
6 secondary outcomes
Dilatation size
Time frame: Immediately after the intervention/procedure/surgery/etc
Perforation rate
Time frame: Immediately after the intervention/procedure/surgery/etc
Bleeding rate
Time frame: Immediately after the intervention/procedure/surgery/etc
Fistula rate
Time frame: One year
Reintervention
Time frame: One year
Readmission
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: Yes
Related trials for Esophageal Stricture
Enrolling by invitation
Adipose-derived Stem Cells in Treatment of Esophageal Strictures
Esophageal Stenosis Acquired
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Prospective Evaluation of AI-ECG for SHD Detection
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
RecruitingObservational study
Abbott Cephea Mitral Valve Disease Registry
Mitral Regurgitation, Mitral Stenosis
Recruiting
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Dysphagia, Esophageal Stricture
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and Esophagogastroduodenoscopy with Balloon Dilatation in people with Esophageal Stricture and Duodenal Stricture, run by University of Southern California at 1 site in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 5 May 2020. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kulmeet Sandhu, MD (323 442 5831, kulmeet.sandhu@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dilatations (time frame: One year). 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 5 May 2020.