Pharyngo-oesphageal StricturesNCT06846801
Balloon Dilation Under Portable X-ray System in the Treatment of Pharyngo-oesphageal Strictures
A study testing Balloon Dilation Under Portable X-ray System in people with Pharyngo-oesphageal Strictures, run by Mohammed Elrabie Ahmed at 2 sites in Egypt.
Trial summary
The aim of our study is to evaluate the outcomes (efficacy and safety) and to present our experience in X-DR portable x-ray system guided endoscopic balloon dilatation in the treatment of pharyngo-oesophageal strictures as an alternative procedure to the videofluroscopic guided maneuver. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pharyngo-oesphageal Strictures
- What is being tested?
- Balloon Dilation Under Portable X-ray System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2024to 30 May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients diagnosed to have oesophageal strictures with clinical and radiological investigation regardless of the age of the patient
Who cannot join
- previously dilated strictures
- neoplastic strictures
- Post-irradiation strictures
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of the Outcomes of Endoscopic Balloon Dilation Under X-DR Portable X-ray System Guidance in the Treatment of Pharyngo-oesphageal Strictures
The aim of our study is to evaluate the outcomes (efficacy and safety) and to present our experience in X-DR portable x-ray system guided endoscopic balloon dilatation in the treatment of pharyngo-oesophageal strictures as an alternative procedure to the videofluroscopic guided maneuver.
Read the detailed description
The study will include 20 patients who will attend to Sohag university hospital and will be diagnosed to have oesophageal strictures regardless of the age of the patient (previously dilated strictures, neoplastic strictures and post-irradiation strictures will be excluded from the study).
- The diagnosis of oesophageal stricture and need of patients for dilatation will be determined according to symptoms such as dysphagia clinical score (simplified dysphagia severity rating scale mentioned previously), decreased tolerance depending on the consistency and caliber of the food pieces, water soluble upper gastrointestinal contrast radiographies, and sometimes the need for flexible upper GIT endoscopy.
- All the esophageal dilation procedures will be performed using rigid hypopharyngoscope and / or oesophagoscope with endotracheal intubation under general anesthesia by experienced surgical and anesthesia team.
- The rigid hypopharyngoscope / oesophagoscope (Storz, germany) will be introduced through the mouth to whole through examination to localize the site of the stenosis then a contrast material will be injected via the endoscope and picture taken with X-DR portable x-ray system.
- After that a guide wire 0.035mm will be passed through the endoscope till the stomach. The guide wire site will be confirmed by with X-DR portable x-ray system and then a suitable size balloon catheter will be passed over the guide wire (Boston Scientific, Cork, Ireland), then the balloon catheter will be advanced through the stricture confirmed by taking a photo by the x-ray system. The balloon will be inflated with radiopaque contrast solution using EncoreTM 26 inflation device. Before inflation, correct placement of the deflated balloon will be checked with X-DR portable x-ray system.
- The length of the balloon will be -35.5 cm, and the diameters range from 6 to 20 mm and will be translucent in color. The balloon will be inflated up to 4-10 atm pressure and kept inflated for 3 to 5 min.
- After confirming the persistence of the ''waist'' and that it will be both endoscopically and image guided safe, the diameter of the balloon will be increased.
- Appropriate balloon catheter size will be determined by the surgeon by evaluating the patient's age, body weight, the severity of the esophageal stricture determined on the barium image.
- After deflation and removal of balloon, the contrast material will be injected through the rigid endoscope and an image by the portable system will be taken as a post dilatation check test for the possibility of oesophageal perforation.
- Antibiotic prophylaxis and proton pump inhibitors will be routinely prescribed unless there will be any complications. All patients will undergo chest X-ray 12 hours after the procedure. If no pathological finding is detected in the patients' examination and chest X-ray, the patients will be encouraged to start feeding orally with gradual introduction of clear fluids, soft food then solids and discharged 3-4 hours after that. Upper GI contrast study will not performed routinely in asymptomatic patients. Patients with severe strictures will be called back after 4-6 weeks. Symptom monitoring will be recommended for patients with mild strictures and no need for dilation for more than 3 months.
- All of the patients' demographic features, primary diagnosis, additional diseases, level of stricture, type of stricture (simple, complex), total number of dilations, balloon sizes used in the first and last dilation, time between dilations, complications due to the procedure, gastrostomy opening, need for additional surgical procedure, therapeutic agent injection, trial of C-mac, preoperative upper GI contrast radiographies, time spent without the need for dilation, and the follow-up time will be recorded and statistically analyzed using the suitable statistical tests.
- Efficacy will be measured by improvements in symptoms (e.g., dysphagia scores, quality of life), the number of dilatation sessions required, and overall long-term outcomes.
- Safety will involve tracking complications, such as perforations, bleeding, and other adverse events
- Conditions
- Pharyngo-oesphageal Strictures
- Being tested
- Balloon Dilation Under Portable X-ray System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Dilation Under Portable X-ray SystemProcedure or surgery
- All the esophageal dilation procedures will be performed using rigid hypopharyngoscope and / or oesophagoscope with endotracheal intubation under general anesthesia by experienced surgical and anesthesia team.
- The rigid hypopharyngoscope / oesophagoscope (Storz, germany) will be introduced through the mouth to whole through examination to localize the site of the stenosis then a contrast material will be injected via the endoscope and picture taken with X-DR portable x-ray system.
- After that a guide wire 0.035mm will be passed through the endoscope till the stomach. The guide wire site will be confirmed by with X-DR portable x-ray system and then a suitable size balloon catheter will be passed over the guide wire (Boston Scientific, Cork, Ireland), then the balloon catheter will be advanced through the stricture confirmed by taking a photo by the x-ray system. The balloon will be inflated with radiopaque contrast solution using EncoreTM 26 inflation device.
| Study group | Role | What they receive |
|---|---|---|
| one | Experimental | 20 patients who will attend to Sohag university hospital and will be diagnosed to have oesophageal strictures regardless of the age of the patient (previously dilated strictures, neoplastic strictures and post-irradiation strictures will be excluded from the study). Receives: Procedure: Balloon Dilation Under Portable X-ray System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatmet of pharyngo-oesphageal strictures
improvements in dysphgia scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Nov 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pharyngo-oesphageal StricturesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 20 patients who will attend to Sohag university hospital and will be diagnosed to have oesophageal strictures regardless of the age of the patient (previously dilated strictures, neoplastic strictures and post-irradiation strictures will be excluded from the study).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Elrabie Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Elrabie Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846801
- Sponsor's protocol ID
- Soh-Med-25-1-9PD
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Standards of Practice Committee; Egan JV, Baron TH, Adler DG, Davila R, Faigel DO, Gan SL, Hirota WK, Leighton JA, Lichtenstein D, Qureshi WA, Rajan E, Shen B, Zuckerman MJ, VanGuilder T, Fanelli RD. Esophageal dilation. Gastrointest Endosc. 2006 May;63(6):755-60. doi: 10.1016/j.gie.2006.02.031. No abstract available.
PubMed 16650533Azizkhan RG, Stehr W, Cohen AP, Wittkugel E, Farrell MK, Lucky AW, Hammelman BD, Johnson ND, Racadio JM. Esophageal strictures in children with recessive dystrophic epidermolysis bullosa: an 11-year experience with fluoroscopically guided balloon dilatation. J Pediatr Surg. 2006 Jan;41(1):55-60; discussion 55-60. doi: 10.1016/j.jpedsurg.2005.10.007.
PubMed 16410108
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Outcomes of Endoscopic Balloon Dilation Under X-DR Portable X-ray System Guidance in the Treatment of Pharyngo-oesphageal Strictures
- ClinicalTrials.gov ID
- NCT06846801
- Acronym / sponsor ID
- Soh-Med-25-1-9PD
- Conditions
- Pharyngo-oesphageal Strictures
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mohammed Elrabie AhmedUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 26 Feb 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.
The aim of our study is to evaluate the outcomes (efficacy and safety) and to present our experience in X-DR portable x-ray system guided endoscopic balloon dilatation in the treatment of pharyngo-oesophageal strictures as an alternative procedure to the videofluroscopic guided maneuver.
Detailed description
The study will include 20 patients who will attend to Sohag university hospital and will be diagnosed to have oesophageal strictures regardless of the age of the patient (previously dilated strictures, neoplastic strictures and post-irradiation strictures will be excluded from the study).
- The diagnosis of oesophageal stricture and need of patients for dilatation will be determined according to symptoms such as dysphagia clinical score (simplified dysphagia severity rating scale mentioned previously), decreased tolerance depending on the consistency and caliber of the food pieces, water soluble upper gastrointestinal contrast radiographies, and sometimes the need for flexible upper GIT endoscopy.
- All the esophageal dilation procedures will be performed using rigid hypopharyngoscope and / or oesophagoscope with endotracheal intubation under general anesthesia by experienced surgical and anesthesia team.
- The rigid hypopharyngoscope / oesophagoscope (Storz, germany) will be introduced through the mouth to whole through examination to localize the site of the stenosis then a contrast material will be injected via the endoscope and picture taken with X-DR portable x-ray system.
- After that a guide wire 0.035mm will be passed through the endoscope till the stomach. The guide wire site will be confirmed by with X-DR portable x-ray system and then a suitable size balloon catheter will be passed over the guide wire (Boston Scientific, Cork, Ireland), then the balloon catheter will be advanced through the stricture confirmed by taking a photo by the x-ray system. The balloon will be inflated with radiopaque contrast solution using EncoreTM 26 inflation device. Before inflation, correct placement of the deflated balloon will be checked with X-DR portable x-ray system.
- The length of the balloon will be -35.5 cm, and the diameters range from 6 to 20 mm and will be translucent in color. The balloon will be inflated up to 4-10 atm pressure and kept inflated for 3 to 5 min.
- After confirming the persistence of the ''waist'' and that it will be both endoscopically and image guided safe, the diameter of the balloon will be increased.
- Appropriate balloon catheter size will be determined by the surgeon by evaluating the patient's age, body weight, the severity of the esophageal stricture determined on the barium image.
- After deflation and removal of balloon, the contrast material will be injected through the rigid endoscope and an image by the portable system will be taken as a post dilatation check test for the possibility of oesophageal perforation.
- Antibiotic prophylaxis and proton pump inhibitors will be routinely prescribed unless there will be any complications. All patients will undergo chest X-ray 12 hours after the procedure. If no pathological finding is detected in the patients' examination and chest X-ray, the patients will be encouraged to start feeding orally with gradual introduction of clear fluids, soft food then solids and discharged 3-4 hours after that. Upper GI contrast study will not performed routinely in asymptomatic patients. Patients with severe strictures will be called back after 4-6 weeks. Symptom monitoring will be recommended for patients with mild strictures and no need for dilation for more than 3 months.
- All of the patients' demographic features, primary diagnosis, additional diseases, level of stricture, type of stricture (simple, complex), total number of dilations, balloon sizes used in the first and last dilation, time between dilations, complications due to the procedure, gastrostomy opening, need for additional surgical procedure, therapeutic agent injection, trial of C-mac, preoperative upper GI contrast radiographies, time spent without the need for dilation, and the follow-up time will be recorded and statistically analyzed using the suitable statistical tests.
- Efficacy will be measured by improvements in symptoms (e.g., dysphagia scores, quality of life), the number of dilatation sessions required, and overall long-term outcomes.
- Safety will involve tracking complications, such as perforations, bleeding, and other adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 patients who will attend to Sohag university hospital and will be diagnosed to have oesophageal strictures regardless of the age of the patient (previously dilated strictures, neoplastic strictures and post-irradiation strictures will be excluded from the study).
| Arm | Type | Receives |
|---|---|---|
| one | Experimental | Procedure: Balloon Dilation Under Portable X-ray System20 patients who will attend to Sohag university hospital and will be diagnosed to have oesophageal strictures regardless of the age of the patient (previously dilated strictures, neoplastic strictures and post-irradiation strictures will be excluded from the study). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed to have oesophageal strictures with clinical and radiological investigation regardless of the age of the patient
Key exclusion criteria (3 listed)
- previously dilated strictures
- neoplastic strictures
- Post-irradiation strictures
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 |
|---|---|---|
| Balloon Dilation Under Portable X-ray System* All the esophageal dilation procedures will be performed using rigid hypopharyngoscope and / or oesophagoscope with endotracheal intubation under general anesthesia by experienced surgical and anesthesia team. * The rigid hypopharyngoscope / oesophagoscope (Storz, germany) will be introduced through the mouth to whole through examination to localize the site of the stenosis then a contrast material will be injected via the endoscope and picture taken with X-DR portable x-ray system. * After that a guide wire 0.035mm will be passed through the endoscope till the stomach. The guide wire site will be confirmed by with X-DR portable x-ray system and then a suitable size balloon catheter will be passed over the guide wire (Boston Scientific, Cork, Ireland), then the balloon catheter will be advanced through the stricture confirmed by taking a photo by the x-ray system. The balloon will be inflated with radiopaque contrast solution using EncoreTM 26 inflation device. | Procedure or surgery | one |
Primary outcome
Treatmet of pharyngo-oesphageal strictures
Time frame: 6 months
improvements in dysphgia scores
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 26 Feb 2025.
- Background: PubMed 16650533Standards of Practice Committee; Egan JV, Baron TH, Adler DG, Davila R, Faigel DO, Gan SL, Hirota WK, Leighton JA, Lichtenstein D, Qureshi WA, Rajan E, Shen B, Zuckerman MJ, VanGuilder T, Fanelli RD. Esophageal dilation. Gastrointest Endosc. 2006 May;63(6):755-60. doi: 10.1016/j.gie.2006.02.031. No abstract available.
- Background: PubMed 16410108Azizkhan RG, Stehr W, Cohen AP, Wittkugel E, Farrell MK, Lucky AW, Hammelman BD, Johnson ND, Racadio JM. Esophageal strictures in children with recessive dystrophic epidermolysis bullosa: an 11-year experience with fluoroscopically guided balloon dilatation. J Pediatr Surg. 2006 Jan;41(1):55-60; discussion 55-60. doi: 10.1016/j.jpedsurg.2005.10.007.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Dilation Under Portable X-ray System in people with Pharyngo-oesphageal Strictures, run by Mohammed Elrabie Ahmed at 2 sites in Egypt.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatmet of pharyngo-oesphageal strictures (time frame: 6 months). 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 NCT06846801, which also lists 2 linked publications.
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 26 Feb 2025.