Endoscopic pneumatic balloon dilation for Constriction, Pathologic

Phase-Based Estimates
1
Effectiveness
1
Safety
Johns Hopkins University, Baltimore, MD
Constriction, Pathologic+1 More
Endoscopic pneumatic balloon dilation - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Constriction, Pathologic

Study Summary

Management of Symptomatic Gastric Sleeve Stenosis After Laparoscopic Sleeve Gastrectomy

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Eligible Conditions

  • Constriction, Pathologic
  • Gastric Stenosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Endoscopic pneumatic balloon dilation will improve 1 primary outcome and 10 secondary outcomes in patients with Constriction, Pathologic. Measurement will happen over the course of Immediately post-procedure.

6 months post-procedure
Rate of clinical success
8 weeks post-procedure
Procedural success as assessed by the PAGI-SYM score
Immediately post-procedure
Rate of technical success
Up to 12months post-procedure
Time to recurrence of symptoms post-treatment in patients with recurrence
Month 6
Degree of axial deviation per Endoscopic resolution of GSS-related findings
Degree of axial deviation per Radiologic resolution of GSS-related findings
Degree of luminal narrowing per Endoscopic resolution of GSS-related findings
Degree of luminal narrowing per Radiologic resolution of GSS-related findings
Percentage of patients maintained off PPI therapy
Presence of delayed contrast flow per Radiologic resolution of GSS-related findings
Rate of adverse events

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment Arm

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Endoscopic Pneumatic Balloon Dilation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment ArmEndoscopic 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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Roux-en-Y gastric bypass (RYGB)
2011
N/A
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12months post-procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12months post-procedure for reporting.

Closest Location

Johns Hopkins University - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for constriction, pathologic?

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The majority of patients were discharged with a nonoperative treatment strategy including medical attention with follow-up visits or at least a one-month course of outpatient therapy that includes medical attention, massage, and physical rehabilitation. The most common nonoperative treatments were the administration of NSAIDs and topical anaesthetic, the use of manual mobilization devices, and medical advice about cessation of smoking.

Unverified Answer

What are the signs of constriction, pathologic?

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Findings may be nonspecific and thus many physical signs may be present without being specific to constriction. Data from a recent study include decreased capillary refill, decreased pulse pressure, ascites, hepatomegaly, and hepatosplenomegaly. Patients with hepatomegaly should be evaluated for the presence of ascites before a diagnosis of constriction can be made.

Unverified Answer

What is constriction, pathologic?

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In the context of this article, constriction refers to a constriction at the level of a joint. This is a very important topic for all healthcare providers. In this article the main focus is on the constriction in the neck and chest of patients who do not tolerate external compression. A patient, whose neck is limited by constriction, has reduced head and neck movement and cannot take off his or her head. His or her chest is restricted when, in coughing or breathing, the chest wall is compressed vertically. The resultant loss of respiratory movements has profound consequences for the patient's life and for the outcome of his/her disease.

Unverified Answer

What causes constriction, pathologic?

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Constricting perivenous scarring can be caused by many conditions, including infection, drug toxicity, trauma and surgery. The scar's appearance is variable and often misleading, so biopsy is essential. Biopsy requires excision of a portion of the scar, but often does not reveal the actual cause of the scar's formation. Clinicians may use biopsies to help confirm the diagnosis and help guide clinical management, including timing of surgical interventions.

Unverified Answer

Can constriction, pathologic be cured?

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CCS is a chronic disorder. It is not a static process like benign hyperplasia, and the cure rate is only 40%. Further research is needed to fully understand the disease. Long-term follow-up data and a prospective approach may prove fruitful in the pursuit of defining the natural history of CCS.

Unverified Answer

How many people get constriction, pathologic a year in the United States?

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The constriction incidence is 10-fold higher than pathologic incidence. The disparity between incidences of pathologic and constriction may involve genetic predispositions, environmental exposures, and lifestyle issues.

Unverified Answer

What is endoscopic pneumatic balloon dilation?

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Endoscopic dilation of strictures with the use of an endoscopic device that uses gas to expand the stricture is a safe, effective, and minimally invasive treatment and should be considered for patients with severe obstructive esophageal disease. It is advisable to perform this procedure in a university tertiary care teaching hospital.

Unverified Answer

Is endoscopic pneumatic balloon dilation safe for people?

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Endoscopic pneumatic BPD is safe for people. Most common complications occurred early after the procedure. The use of BPD may be beneficial for people in order to prevent the need for open procedures. The potential benefit of endoscopic BPD should be weighed against the risk of complications. In order to perform the procedure safely, a thorough understanding of technical requirements is imperative.

Unverified Answer

How serious can constriction, pathologic be?

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[Appendectomy in the past 30-day period is associated with approximately 5 more days of hospitalization or procedural-based costs compared with nonoperative management for diverticulitis with pathologic finding.

Unverified Answer

Has endoscopic pneumatic balloon dilation proven to be more effective than a placebo?

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Endoscopic pneumatic balloon dilation using a 6-mm balloon at a pressure of 10 to 11 atmospheres is more effective than placebo in the prevention of post-ERCP pancreatitis, albeit the effect is not statistically different in the prevention of hyperamylasemia or cholangitis. The combination of pneumatic dilation with a sphincterotome technique for choledocholithiasis, such as T-tube decompression, may improve endoscopic papillary balloon dilation. Endoscopic papillary balloon dilatation can become routine.

Unverified Answer

What is the average age someone gets constriction, pathologic?

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Approximately 40% of people with constriction or aneurysm will be diagnosed after age 80. In order to keep up with population demographics, surgeons should be aware of the natural history of this disease and consider it in their differential diagnosis when treating patients with berry aneurysmal disease.

Unverified Answer

Have there been other clinical trials involving endoscopic pneumatic balloon dilation?

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Although EBD was successful with the treatment of symptomatic esophageal strictures in this retrospective study, longer term follow-up and better results with controlled studies are needed.

Unverified Answer
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