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Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial).

ABSTRACT: INTRODUCTION:Anastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and thereby to prevent stricture recurrence. We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children. METHODS AND ANALYSIS:This is an international multicentre randomised controlled trial. Children with OA type C (n=110) will be randomised into intralesional steroid injection followed by balloon dilatation or dilatation only. Randomisation and intervention will take place when a third dilatation is performed. The indication for dilatation will be confirmed with an oesophagram. One radiologist-blinded for randomisation-will review all oesophagrams. The primary outcome parameter is the total number of dilatations needed with <28 days' interval, which will be analysed with a linear-by-linear ?2 association test. Secondary outcome parameters include the level of dysphagia, the luminal oesophageal diameter and stricture length (measured on the oesophagrams), the influence of comedication on stricture formation, systemic effects of intralesional steroids (cortisol levels, length and weight) and the cost-effectiveness. Patients will undergo a second oesophagram; length and weight will be measured repeatedly; a scalp hair sample will be collected; and three questionnaires will be administered. The follow-up period will be 6?months, with evaluation at 2-3 weeks, 3 and 6 months after the intervention. ETHICS AND DISSEMINATION:Patients will be included after written parental informed consent. The risks and burden associated with this trial are minimal. The institutional review board of the Erasmus Medical Centre approved this protocol (MEC-2018-1586/NL65364.078.18). The results of the trial will be published in a peer-reviewed scientific journal and will be presented at international conferences. TRIAL REGISTRATION NUMBERS:2018-002863-24 and NTR7726/NL7484.

SUBMITTER: Ten Kate CA

PROVIDER: S-EPMC6937109 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial).

Ten Kate Chantal A CA Vlot John J IJsselstijn Hanneke H Allegaert Karel K Spaander Manon C W MCW Poley Marten J MJ van Rosmalen Joost J van den Akker Erica L T ELT Wijnen Rene M H RMH

BMJ open 20191216 12

<h4>Introduction</h4>Anastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and thereby to prevent stricture recurrence. We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children.<h4>Methods ...[more]

PMID: 31848172

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Project description:Importance:Endoscopic dilation is the mainstay treatment strategy for subglottic and proximal tracheal stenosis (SGS/PTS). Its major limitation is restenosis requiring repeated surgery. Intralesional steroid injection (ISI) is a promising adjunctive treatment aimed at prolonging the effects of dilation. Objective:To evaluate the association of serial in-office ISI after endoscopic dilation with surgery-free interval (SFI) in adults with SGS/PTS. Design, Setting, and Participants:A retrospective study of adults with SGS/PTS who underwent at least 2 consecutive in-office ISI at the University of Southern California, Keck School of Medicine, over a 3-year period was conducted. Exposure:Serial ISI with triamcinolone 40 mg/mL using topical anesthesia, spaced 3 to 6 weeks apart. Main Outcomes and Measures:Surgery-free interval, number of dilations, need for open airway surgery, decannulation rate, and adverse events. Patients with previous dilations and sufficient follow-up time were included in a comparative analysis of SFI before and after ISI. The Mann-Whitney U test was applied for comparisons. Results:Twenty-four patients met eligibility criteria. Mean (SD) age was 50.1 (15.1) years; 18 (75%) were female. Ten (42%) patients had idiopathic, 8 (33%) had traumatic, and 6 (25%) had rheumatologic-related SGS/PTS. Mean (SD) follow-up time was 32.3 (33.4) months. Patients underwent mean (SD) 4.08 (1.91) injections. Seventeen (71%) patients have not undergone further surgery after ISI. Mean (SD) SFI was 17.8 (12.8) months overall and was 15.7 (10.6) months for idiopathic, 13.8 (9.9) for traumatic, and 26.7 (16.9) for rheumatologic-related SGS/PTS. Twenty-one (88%) patients underwent dilation(s) prior to ISI. Among patients who fulfilled eligibility criteria for comparison of SFI before and after ISI, SFI improved from 10.1 months before, to 22.6 months after ISI (mean difference, 12.5 months; 95% CI, -2.1 to 27.2 months). Three of 6 patients (all with traumatic SGS/PTS) presenting with a tracheotomy were decannulated. No patients required open airway surgery after ISI. There were no adverse events associated with ISI. Conclusions and Relevance:Serial in-office ISI are safe and well-tolerated in adults with SGS/PTS. This technique can reduce the surgical burden on these patients and may obviate the need for future airway intervention.

Project description:BackgroundKeloid disease is hard to fully eradicate. Recurrence and other unsatisfactory results were found in many patients. No current therapeutic modality has been determined to be most effective for treating keloid scars. Intralesional corticosteroid injections is most commonly recommended for primary management of small and young keloids as well as hypertrophic scars. However, it's difficult for patients to adhere to long-term triamcinolone acetonide injection therapy because of the pain, inconvenience or complications including hormonal imbalance or irregular menstruation.ObjectiveWe aimed to determine whether and how Strontium-90 brachytherapy as an adjuvant radiation could affect keloid recurrence after intralesional triamcinolone and 5-fluorouracil injections.MethodsWe included keloid patients from March 2019 to September 2019 and randomly allocated them to two groups after 3 intralesional triamcinolone and 5-fluorouracil injections at 3 weeks interval. The experimental group received Strontium-90 brachytherapy at a total dose of 15-20Gy, while the control group didn't receive any adjuvant treatment. We performed both Vancouver Scar Scale scoring and Color Doppler ultrasound examination to monitor and evaluate lesions regularly. A one-year follow-up was completed for each patient.Results31 patients who had 42 keloids in total were recruited. We found intralesional triamcinolone and 5-fluorouracil injections could effectively reduce the thickness and modify the hardness of small and young keloids. Strontium-90 brachytherapy reduced the one-year recurrence rate from 85.7 percent to 44.4 percent after 3 intralesional triamcinolone and 5-fluorouracil injections. The lesions' thickness or elasticity was not affected by Strontium-90 brachytherapy.ConclusionStrontium-90 brachytherapy as an adjuvant radiation could effectively reduce small sized keloids recurrence after intralesional triamcinolone and 5-fluorouracil injections. It worked by enhancing the lesions' stability post-injection.Trial registrationThe clinical trial registration number: ChiCTR2000030141. Name of trial registry: Chinese Clinical Trial Registry (http://www.chictr.org.cn/).

Project description:INTRODUCTION:Osteoarthritis of the trapeziometacarpal joint affects approximately 10%-25% of women, especially those who are postmenopausal. It may result in thumb dysfunction. Among the treatments, intra-articular injections of corticosteroid (CS) and hyaluronic acid (HA) are both effective and recommended. However, clinical trials have shown that HA improves functional capacity, whereas CS only produces a decrease in pain. The synergy of these two drugs has not been evaluated. The primary goal of this study was to determine whether the association between HA and CS produce an additional decrease of more pain during thumb movement at three months postinjection, compared to the level of pain relief from CS alone. METHODS AND ANALYSIS:RHIZ'ART is a prospective, multicentre, comparative, randomised, controlled, double-blind trial. Patients referred to the rheumatology department for thumb rhizarthrosis will receive an injection of betamethasone with HA or placebo (serum saline) based on central randomisation and stratification by centre. Injections will be given under ultrasound guidance. The primary outcome will compare the pain Visual Analogue Scale with motion at three months for both groups using a mixed model. The expected decrease in pain intensity in the CS group is 25% and 35% in the CS with HA group. In order to achieve a 80% power for detecting this difference with ? set at 5%, 73 patients are needed in each group (146 total). The main secondary outcomes are the Cochin score (hand function) and grip strength. Follow-up visits are at 1, 3, 6 and 12 months. ETHICS AND DISSEMINATION:The study project has been approved by the appropriate ethics committee (CPP île de France III, 2017-002298-20). In agreement with current French regulations, a signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT03431584.

Project description:BackgroundLumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.MethodsWe will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.DiscussionThis study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.Trial registrationClinicaltrials.gov NCT01238536.

Dataset Information

Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial).

Publications

Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial).

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