Gastric StenosisNCT04781946
Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
A study testing Endoscopic pneumatic balloon dilation, Gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB) in people with Gastric Stenosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The global obesity epidemic has led to increasing popularity of bariatric surgeries and a parallel rise in the prevalence of related complications. Gastric sleeve stenosis (GSS) complicates 0.1-3.9% of cases after Sleeve Gastrectomy (SG) and can result in significant symptoms including nausea, vomiting, epigastric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Stenosis
- What is being tested?
- Endoscopic pneumatic balloon dilation, Gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 1 Jul 2023
- 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
- Patients with symptoms of dysphagia, abdominal pain, nausea, vomiting, heartburn or regurgitation after LSG that do not respond to standard medical therapies, such as proton pump inhibitors, anti-emetics, etc
- Patients with a confirmed sleeve stenosis by contrast study and/or upper endoscopy
- Adult patients aged greater than 18 years old at time of consent
- Patients able to provide written informed consent on the Institutional Review Board/Ethics Committee-approved informed consent form
- Patients willing and able to comply with study requirements for follow up
Who cannot join
- Presence of concomitant gastric leak or fistula
- Stenosis of non-gastric origin
- History of Roux-en-Y gastric bypass, or duodenal switch
- GSS within one month after sleeve gastrectomy
- Severe medical comorbidities precluding endoscopy or surgery, or limiting life expectancy to less than 2 years in the judgement of the endoscopist
- Uncontrolled coagulopathy or inability to be off anticoagulation or antiplatelet medication for 1 week prior to and after intervention
- Pregnant or planning to become pregnant during period of study participation
- Patient refuses or is unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Clinical Trial on the Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
The global obesity epidemic has led to increasing popularity of bariatric surgeries and a parallel rise in the prevalence of related complications. Gastric sleeve stenosis (GSS) complicates 0.1-3.9% of cases after Sleeve Gastrectomy (SG) and can result in significant symptoms including nausea, vomiting, epigastric pain, dysphagia, reflux and regurgitation. There is no validated algorithm for the management of GSS, and available literature is retrospective.
The investigators hypothesize that the implementation of a predefined treatment algorithm for management of GSS post SG will effectively and safely manage patients with this condition. This single center, prospective, non-randomized pilot clinical trial to be performed at Johns Hopkins Medical Institutes will describe the efficacy and safety of endoscopic pneumatic balloon dilation (PBD), gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB) for the management of post-LSG GSS using a predefined treatment algorithm. Patients with symptomatic, endoscopically or radiologically confirmed GSS greater than four weeks from laparoscopic sleeve gastrectomy (LSG) who are treatment naïve will be included.
The primary outcome is the rate of clinical success, defined an improvement in symptoms that allowed the patient to avoid further intervention (outside of the predefined treatment algorithm) with a resumption of adequate oral intake and at least 1-point reduction in the Patient Assessment of upper Gastrointestinal Symptoms (PAGI-SYM) questionnaire, at 6 months following last intervention. Secondary outcomes include rates of technical success (completion of planned procedure), procedural success (defined as a 1-point reduction in PAGI-SYM score at 8 weeks following procedure), endoscopic and radiologic resolution of GSS-related findings, percentage of patients maintained off proton pump inhibitor (PPI) therapy, time to recurrence of symptoms post-treatment in patients with recurrence, and rate of adverse events. The expected study population is 30 participants with a study duration of 18 months. This study can potentially validate a treatment algorithm, thereby assisting clinicians to select the most appropriate intervention for the treatment of post-LSG GSS. Moreover, it may help improve outcomes and prevent unnecessary procedures in patients with GSS.
Read the detailed description
Gastric sleeve stenosis (GSS) can either be mechanical from a short, circumferential stricture (non-helical) or functional secondary to an axial deviation (helical). Helical GSS are believed to be due to asymmetric traction and/or misalignment while stapling, causing a rotated gastric sleeve and functional obstruction to flow. Current treatment options include: endoscopic pneumatic balloon dilation (PBD), endoscopic stenting and revision surgery. Endoscopic balloon dilation demonstrates an overall clinical success rate of 76%[ and usually requires more than one session. However, the optimal size and type of balloon used, as well as the frequency of dilations remains unclear. Additionally, the accessibility and length of the GSS will also impact balloon choice and can occasionally prohibit balloon placement or distension. Endoscopic placement of fully covered self-expanding metal stents (FCSEMS) are effective in 70% of EBD failures. However, FCSEMS have a migration risk of up to 62% in the post-bariatric stricture setting, which may be reduced by suturing. Further, both of these treatment modalities have limited long term success in the setting of helical GSS. Revision surgery, usually a conversion to RYGB is effective in 91% of EBD failures - however can be associated with high adverse event rates. Gastric per-oral endoscopic myotomy (G-POEM) is a recent innovation offering a minimally invasive endoscopic approach. G-POEM allows for the creation of a tunnel and subsequent myotomy from the gastric cardia to the gastric pylorus. Initially developed for the treatment of gastroparesis, case reports have now demonstrated its successful use in post-LSG GSS. A modification to the original technique allows the staple line to be targeted for myotomy, relieving the tortuosity seen in a helical GSS. Case reports and retrospective studies have been supportive of this but there is no prospective data. Currently, there are no clear guidelines on the management of GSS post-LSG and available literature is largely retrospective. Hence, we sought to prospectively evaluated the use of G-POEM for management of patients with symptomatic, endoscopically or radiologically confirmed helical GSS
- Conditions
- Gastric Stenosis
- Being tested
- Endoscopic pneumatic balloon dilation, Gastric peroral endoscopic myotomy (G-POEM), Roux-en-Y gastric bypass (RYGB)
- Keywords
- gastric stenosis, laparoscopic sleeve gastrectomy, bariatric complications, endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic pneumatic balloon dilationProcedure or surgery
Using endoscopy, pneumatic balloon dilation may be used to treat stenosis of the gastric sleeve.
Gastric peroral endoscopic myotomy (G-POEM)Procedure or surgery
Gastric per-oral endoscopic myotomy (G-POEM) is a recent innovation offering a minimally invasive endoscopic approach. G-POEM allows for the creation of a tunnel and subsequent myotomy from the gastric cardia to the gastric pylorus.
Roux-en-Y gastric bypass (RYGB)Procedure or surgery
The Roux-en-Y gastric bypass is a type of weight-loss surgery that involves creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Endoscopic pneumatic balloon dilation (PBD), gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB) will be used for the management of post-LSG GSS using a predefined treatment algorithm. Receives: Procedure: Endoscopic pneumatic balloon dilation; Procedure: Gastric peroral endoscopic myotomy (G-POEM); Procedure: Roux-en-Y gastric bypass (RYGB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical success
The rate of clinical success, defined as an improvement in symptoms that allowed the patient to avoid further intervention (outside of the predefined treatment algorithm) with a resumption of adequate oral intake and at least 1-point reduction in the Patient Assessment of upper Gastrointestinal Symptoms (PAGI-SYM) questionnaire, at 6 months following last intervention.
Measured: 6 months post-procedure
Secondary outcomes (10)
Rate of technical success
Defined as the completion of planned procedure.
Measured: Immediately post-procedure
Procedural success as assessed by the PAGI-SYM score
Procedural success is defined as a 1-point reduction in PAGI-SYM score at 8 weeks following procedure.
Measured: 8 weeks post-procedure
Degree of axial deviation per Endoscopic resolution of GSS-related findings
Degree of axial deviation post-treatment measured in degrees.
Measured: Up to 6 months post-procedure
Degree of luminal narrowing per Endoscopic resolution of GSS-related findings
Degree of luminal narrowing post-treatment measured as a ratio of the diameter of the narrowest portion over the widest portion of the sleeve.
Measured: Up to 6 months post-procedure
Degree of axial deviation per Radiologic resolution of GSS-related findings
Degree of axial deviation post-treatment measured categorically as: none, mild, moderate or severe.
Measured: Up to 6 months post-procedure
Degree of luminal narrowing per Radiologic resolution of GSS-related findings
Degree of luminal narrowing post-treatment measured as a ratio of the diameter of the narrowest portion over the widest portion of the sleeve.
Measured: Up to 6 months post-procedure
Presence of delayed contrast flow per Radiologic resolution of GSS-related findings
Presence of delayed contrast flow post-treatment measured as either a yes or no.
Measured: Up to 6 months post-procedure
Percentage of patients maintained off PPI therapy
Percentage of patients maintained off proton pump inhibitor (PPI) therapy.
Measured: Up to 6 months post-procedure
Time to recurrence of symptoms post-treatment in patients with recurrence
Measured in days.
Measured: Up to 12months post-procedure
Rate of adverse events
Rate of adverse events will be determined by assessing the number of adverse events.
Measured: Up to 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start30 Aug 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: Decided not to move forward with the study.
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 Gastric StenosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouen A Khashab, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781946
- Sponsor's protocol ID
- IRB00269201
- Status last verified
- Jul 2023
- First submitted
- 1 Mar 2021
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burgos AM, Csendes A, Braghetto I. Gastric stenosis after laparoscopic sleeve gastrectomy in morbidly obese patients. Obes Surg. 2013 Sep;23(9):1481-6. doi: 10.1007/s11695-013-0963-6.
PubMed 23604695
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial on the Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04781946
- Acronym / sponsor ID
- IRB00269201
- Conditions
- Gastric Stenosis
- Keywords
- gastric stenosis, laparoscopic sleeve gastrectomy, bariatric complications, endoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided not to move forward with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 4 Mar 2021 (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 global obesity epidemic has led to increasing popularity of bariatric surgeries and a parallel rise in the prevalence of related complications. Gastric sleeve stenosis (GSS) complicates 0.1-3.9% of cases after Sleeve Gastrectomy (SG) and can result in significant symptoms including nausea, vomiting, epigastric pain, dysphagia, reflux and regurgitation. There is no validated algorithm for the management of GSS, and available literature is retrospective.
The investigators hypothesize that the implementation of a predefined treatment algorithm for management of GSS post SG will effectively and safely manage patients with this condition. This single center, prospective, non-randomized pilot clinical trial to be performed at Johns Hopkins Medical Institutes will describe the efficacy and safety of endoscopic pneumatic balloon dilation (PBD), gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB) for the management of post-LSG GSS using a predefined treatment algorithm. Patients with symptomatic, endoscopically or radiologically confirmed GSS greater than four weeks from laparoscopic sleeve gastrectomy (LSG) who are treatment naïve will be included.
The primary outcome is the rate of clinical success, defined an improvement in symptoms that allowed the patient to avoid further intervention (outside of the predefined treatment algorithm) with a resumption of adequate oral intake and at least 1-point reduction in the Patient Assessment of upper Gastrointestinal Symptoms (PAGI-SYM) questionnaire, at 6 months following last intervention. Secondary outcomes include rates of technical success (completion of planned procedure), procedural success (defined as a 1-point reduction in PAGI-SYM score at 8 weeks following procedure), endoscopic and radiologic resolution of GSS-related findings, percentage of patients maintained off proton pump inhibitor (PPI) therapy, time to recurrence of symptoms post-treatment in patients with recurrence, and rate of adverse events. The expected study population is 30 participants with a study duration of 18 months. This study can potentially validate a treatment algorithm, thereby assisting clinicians to select the most appropriate intervention for the treatment of post-LSG GSS. Moreover, it may help improve outcomes and prevent unnecessary procedures in patients with GSS.
Detailed description
Gastric sleeve stenosis (GSS) can either be mechanical from a short, circumferential stricture (non-helical) or functional secondary to an axial deviation (helical). Helical GSS are believed to be due to asymmetric traction and/or misalignment while stapling, causing a rotated gastric sleeve and functional obstruction to flow. Current treatment options include: endoscopic pneumatic balloon dilation (PBD), endoscopic stenting and revision surgery. Endoscopic balloon dilation demonstrates an overall clinical success rate of 76%[ and usually requires more than one session. However, the optimal size and type of balloon used, as well as the frequency of dilations remains unclear. Additionally, the accessibility and length of the GSS will also impact balloon choice and can occasionally prohibit balloon placement or distension. Endoscopic placement of fully covered self-expanding metal stents (FCSEMS) are effective in 70% of EBD failures. However, FCSEMS have a migration risk of up to 62% in the post-bariatric stricture setting, which may be reduced by suturing. Further, both of these treatment modalities have limited long term success in the setting of helical GSS. Revision surgery, usually a conversion to RYGB is effective in 91% of EBD failures - however can be associated with high adverse event rates. Gastric per-oral endoscopic myotomy (G-POEM) is a recent innovation offering a minimally invasive endoscopic approach. G-POEM allows for the creation of a tunnel and subsequent myotomy from the gastric cardia to the gastric pylorus. Initially developed for the treatment of gastroparesis, case reports have now demonstrated its successful use in post-LSG GSS. A modification to the original technique allows the staple line to be targeted for myotomy, relieving the tortuosity seen in a helical GSS. Case reports and retrospective studies have been supportive of this but there is no prospective data. Currently, there are no clear guidelines on the management of GSS post-LSG and available literature is largely retrospective. Hence, we sought to prospectively evaluated the use of G-POEM for management of patients with symptomatic, endoscopically or radiologically confirmed helical GSS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Procedure: Endoscopic pneumatic balloon dilation, Procedure: Gastric peroral endoscopic myotomy (G-POEM), Procedure: Roux-en-Y gastric bypass (RYGB)Endoscopic pneumatic balloon dilation (PBD), gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB) will be used for the management of post-LSG GSS using a predefined treatment algorithm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with symptoms of dysphagia, abdominal pain, nausea, vomiting, heartburn or regurgitation after LSG that do not respond to standard medical therapies, such as proton pump inhibitors, anti-emetics, etc
- Patients with a confirmed sleeve stenosis by contrast study and/or upper endoscopy
- Adult patients aged greater than 18 years old at time of consent
- Patients able to provide written informed consent on the Institutional Review Board/Ethics Committee-approved informed consent form
- Patients willing and able to comply with study requirements for follow up
Key exclusion criteria (8 listed)
- Presence of concomitant gastric leak or fistula
- Stenosis of non-gastric origin
- History of Roux-en-Y gastric bypass, or duodenal switch
- GSS within one month after sleeve gastrectomy
- Severe medical comorbidities precluding endoscopy or surgery, or limiting life expectancy to less than 2 years in the judgement of the endoscopist
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 pneumatic balloon dilationUsing endoscopy, pneumatic balloon dilation may be used to treat stenosis of the gastric sleeve. | Procedure or surgery | Treatment Arm |
| Gastric peroral endoscopic myotomy (G-POEM)Gastric per-oral endoscopic myotomy (G-POEM) is a recent innovation offering a minimally invasive endoscopic approach. G-POEM allows for the creation of a tunnel and subsequent myotomy from the gastric cardia to the gastric pylorus. | Procedure or surgery | Treatment Arm |
| Roux-en-Y gastric bypass (RYGB)The Roux-en-Y gastric bypass is a type of weight-loss surgery that involves creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine. | Procedure or surgery | Treatment Arm |
Primary outcome
Rate of clinical success
Time frame: 6 months post-procedure
The rate of clinical success, defined as an improvement in symptoms that allowed the patient to avoid further intervention (outside of the predefined treatment algorithm) with a resumption of adequate oral intake and at least 1-point reduction in the Patient Assessment of upper Gastrointestinal Symptoms (PAGI-SYM) questionnaire, at 6 months following last intervention.
10 secondary outcomes
Rate of technical success
Time frame: Immediately post-procedure
Procedural success as assessed by the PAGI-SYM score
Time frame: 8 weeks post-procedure
Degree of axial deviation per Endoscopic resolution of GSS-related findings
Time frame: Up to 6 months post-procedure
Degree of luminal narrowing per Endoscopic resolution of GSS-related findings
Time frame: Up to 6 months post-procedure
Degree of axial deviation per Radiologic resolution of GSS-related findings
Time frame: Up to 6 months post-procedure
Degree of luminal narrowing per Radiologic resolution of GSS-related findings
Time frame: Up to 6 months post-procedure
Presence of delayed contrast flow per Radiologic resolution of GSS-related findings
Time frame: Up to 6 months post-procedure
Percentage of patients maintained off PPI therapy
Time frame: Up to 6 months post-procedure
Time to recurrence of symptoms post-treatment in patients with recurrence
Time frame: Up to 12months post-procedure
Rate of adverse events
Time frame: Up to 6 months post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 23604695Burgos AM, Csendes A, Braghetto I. Gastric stenosis after laparoscopic sleeve gastrectomy in morbidly obese patients. Obes Surg. 2013 Sep;23(9):1481-6. doi: 10.1007/s11695-013-0963-6.
- 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.
Mouen A Khashab, MD principal investigator
Johns Hopkins University
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 pneumatic balloon dilation, Gastric peroral endoscopic myotomy (G-POEM) and Roux-en-Y gastric bypass (RYGB) in people with Gastric Stenosis, run by Johns Hopkins University 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 8 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: withdrawn, as of the sponsor's last update on 13 Jul 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of clinical success (time frame: 6 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 NCT04781946, 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 13 Jul 2023.