Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture
Esophageal StenosisEndoscopic resection of superficial esophageal neoplasms is already a reality and presents important advantages when compared to esophagectomy as fewer complications and better quality of life. However, extensive resections can lead to difficult-to-manage stenoses. There are several therapies available in order to prevent this stenosis but, to date, there is no definition of the gold standard. The objective of this study was to compare the use of intralesional steroid injection versus oral prednisolone after endoscopic submucosal dissection and to evaluate the stenosis rate, number of dilations to resolve the stenosis and complications.
Barretts oEsophageal Resection With Steroid Therapy Trial
Barrett EsophagusEsophageal StenosisBarretts mucosa is a premalignant condition of the oesophagus, which can progress to cancer. Oesophageal cancer is aggressive, with a 5 year survival of only ~15%. High risk Barretts mucosa, containing high grade dysplasia or early cancer, can be removed by endoscopic mucosal resection (EMR) during gastroscopy. If patients can be effectively treated by EMR while they have premalignant or early malignant disease, it is a curative procedure. Currently, the major limitation of Complete Barretts Excision (CBE) by EMR, is scar tissue development in the oesophagus, leading to stricture formation and difficulty swallowing (dysphagia). If a safe and effective method could be found to reduce this risk, the treatment options for early oesophageal cancer would be greatly improved. CBE is performed as a two stage procedure, with 2 gastroscopies 8 weeks apart. In this randomised, doubleblind study, eligible and enrolled patients are randomised after the 1st stage CBE to receive either prednisolone tablets or placebo. Inclusion criteria are patients with short segment (<3cm circumferential disease) Barretts oesophagus with high grade dysplasia or early cancer. The treatment period is for 6 weeks after both CBE sessions. Prednisolone is given in a reducing dose over the 6 weeks, starting at 40mg daily. The primary outcome is symptomatic dysphagia development. Endoscopic dilation will be performed as required for dysphagia secondary to symptomatic oesophageal stricture formation persisting for ≥2 days, or complete dysphagia for any time period. Endoscopic surveillance with biopsies will occur at a 3 month, 6 month then 12 month interval following CBE, to assess for complete removal of Barretts mucosa. Following two stage CBE, stricture rates without preemptive therapy in noncircumferential, circumferential <2cm, and circumferential <3cm disease, are estimated to be 30%, 50% and 70% respectively. The investigators predict a 50% reduction in stricture rate with oral steroid therapy. With a primary analyses of oral steroid versus placebo tested at a 5% level of significance in a two tailed test, 58 patients are needed per group. Allowing for a 5% drop out rate, a total of 126 patients are required. The study will be performed at five Australian Tertiary Hospitals, and the recruitment period is estimated to be 2 years.
Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial
Benign Esophageal StrictureA randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation compared to conservative esophageal dilation in patients with severe benign esophageal strictures.
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures...
Esophageal StrictureFat GraftIn this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to dilation therapy in the treatment of benign esophageal strictures.
The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children...
Esophageal StrictureTo evaluate the efficacy of Intra-lesional triamcinolone injection in the management of refractory benign esophageal Stricture in children.
Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children
Esophageal StrictureCaustic Esophageal Stricture2 moreThis study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures. This is a crossover, controlled, clinical trial in which children with esophageal stricture will be randomized in two groups to receive either topical mitomycin or no additional treatment during standard esophageal dilation session.
PEG by Introducer Method Via EG Scan
DysphagiaAspiration1 morePercutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and easy to perform. However, it is limited by its need to be performed in an endoscopy unit. E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any hospital setting and introduced via nasal approach. Our aim is to prove that PEG by introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at hospitals and medical facilities without endoscopic units.
Cryoablation for Benign Gastrointestinal Anastomotic Strictures
Esophageal StrictureDuodenal Stricture2 moreAnastomotic 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.
trūFreeze® Spray Cryotherapy Patient Registry
Barrett EsophagusEsophageal Dysplasia4 moreTo collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
Esophageal Anastomotic StrictureThis study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.