2018 forwards medical reports

More Medical Studies

for Baby’s and Adults

Born unable to Swallow.

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July 09, 2018

  • Dilation with balloon or bougie was compared with the use of biodegradable stents for the treatment of patients with benign esophageal strictures with a follow-up of 12 months in this multicenter randomized trial. At 3 months, the biodegradable stent group underwent significantly fewer dilations compared with the dilation-only group; but, at 6 months, there was no difference between the two groups in terms of the number of dilations required. The median time to the first dilation for recurrent stricture was significantly longer in the stent group. There was no difference between the two groups in the rate of adverse events, but tracheoesophageal fistulas occurred in 2 patients in the stent group. Both groups experienced significant improvement in dysphagia scores, but without a difference in scores between the two groups.
  • Compared with dilation alone, biodegradable stents may offer a short-term benefit for patients with benign esophageal strictures.

    Abstract

    BACKGROUND

    Dilation is the standard of care for recurrent benign esophageal strictures (BES). Biodegradable stents may prolong the effect of dilation and reduce recurrences. Efficacy and safety of dilation and biodegradable stent placement early in the treatment algorithm of recurrent BES were compared.

    METHODS

    This multicenter, randomized study enrolled patients with BES treated with previous dilations to ≥ 16 mm. The primary endpoint was a number of repeat endoscopic dilations for recurrent stricture within 3 and 6 months. Secondary outcomes through 12 months included safety, time to the first dilation for recurrent stricture, dysphagia, and level of activity.

    RESULTS

    At 3 months, the biodegradable stent group (n = 32) underwent significantly fewer endoscopic dilations for recurrent stricture compared with the dilation group (n = 34; P < 0.001). By 6 months, the groups were similar. The number of patients experiencing adverse events was similar between the groups. Two patients in the biodegradable stent group died after developing tracheoesophageal fistulas at 95 and 96 days post-placement; no deaths were attributed to the stent. Median time to the first dilation of recurrent stricture for the biodegradable stent group was significantly longer (106 vs. 41.5 days; P = 0.003). Dysphagia scores improved for both groups. Patients in the biodegradable stent group had a significantly higher level of activity through 12 months (P < 0.001).

    CONCLUSION

    Biodegradable stent placement is associated with a temporary reduction in a number of repeat dilations and prolonged time to recurrent dysphagia compared with dilation. Additional studies are needed to better define the exact role of biodegradable stent placement to treat recurrent BES.

July 04, 2018

  • Fully covered self-expanding metal stents were compared with partially covered self-expanding metal stents for treatment of patients with malignant esophageal strictures during a median follow-up of 54 days in this multicenter, randomized controlled trial. There was no difference between the two stents in terms of recurrent obstruction, including stent migration or time to recurrent obstruction. There was also no difference in major adverse events between the two stents. Multivariable analysis did not reveal any significant risk factors for recurrent obstruction.
  • There was no difference in the rate of recurrent obstruction between fully-covered and partially-covered self-expanding metal stents in the treatment of malignant esophageal strictures.– Samuel Han, MDWritten by

    Malignant dysphagia is commonly palliated by placing self-expandable metal stents (SEMS). Although tissue ingrowth into the crevices of the stent leads to better fixation and lower migration rates, recurrent dysphagia from tissue ingrowth can occur with uncovered SEMS. Hence, uncovered stents were replaced with partially covered SEMS (PC-SEMS), where the upper and lower ends of the stents are left uncovered for benign tissue ingrowth to anchor the stent. Reports of secondary dysphagia from tissue ingrowth led to the development of fully covered SEMS (FC-SEMS). However, secondary to lack of tissue ingrowth, higher migration rates were reported with FC-SEMS. Another major difference between PC-SEMS and FC-SEMS is the property of removability (although not yet FDA cleared for this indication). PC-SEMS tend to get embedded with tissue ingrowth; hence, these stents cannot be removed safely as compared with FC-SEMS.

    The majority of the studies evaluating these SEMS have been either small case series or nonrandomized, retrospective studies. These authors need to be congratulated for performing this prospective randomized study. A total of 98 patients were randomized 1:1 to either the FC-SEMS or the PC-SEMS. All SEMS were of the woven design, 18 mm in diameter, and similar in all other aspects except for the silicone covering. The primary endpoint measured was recurrent dysphagia, which was observed to be similar in the two groups (19% vs 22%; P = .65). Similarly, dysphagia relief and adverse events were also similar in the two groups. Hence, the authors conclude that fully covering the stent does not offer any additional benefits compared with partially covering it. Because SEMS from only one company were used (woven design), these results cannot be extrapolated to other FC-SEMS such as laser-cut FC-SEMS or fully-covered self-expandable plastic stents.

    The low migration rate of the FC-SEMS observed in this study (around 8%) is contrary to what has been published in the literature (up to 40%),1,2 and this may have impacted the results. The reason for this low migration rate is not clear. The authors speculate that the “dog-bone” design of the stent with the covering on the inside may have prevented migration. Besides 4 patients with stent migration, there were an additional 4 patients with recurrent dysphagia in the FC-SEMS group secondary to tissue overgrowth, which was observed only at the proximal end of the stent. Could this have been 2- to 3-cm distal migration of the FC-SEMS rather than “overgrowth,” making a total of 8 of 48 (17%) migrations? Other details—such as how many stents were placed across the GEJ in the two groups, what was the baseline diameter of the stricture in the two groups, was pre-insertion dilatation done, were those with prior SEMS (FC or PC) excluded from enrollment, and what were the reasons of SEMS dysfunction (migration, in-growth, type of stent used)—would have been useful. With similar efficacies of FC-SEMS and PC-SEMS demonstrated in this study, the question is which stent should one use to palliate malignant dysphagia? One deciding factor could be the cost. FC-SEMS tend to be more expensive. Secondly, repositioning the SEMS, as required in 3 patients in this study, is easier with FC-SEMS, especially if needed after a delay of several weeks. Lastly, and an important factor to decide on the type of SEMS, is the need for removing the SEMS.

Cont:

Although the authors conclude that FC-SEMS do not offer any additional benefits compared with PC-SEMS, there were 4 instances in this study where the authors had to remove the stent: tracheal compression in 1, intractable severe pain in 2, and no relief in 1. FC-SEMS are obviously easier to remove, especially if they are of the woven design as used in this study.

Other reasons to remove SEMS are delayed adverse events. Similar to other studies, both, FC- and PC- SEMS in this study were associated with high adverse events (40% versus 49%, respectively). The longer the stents are in place, more are the chances of developing an adverse event.3 Hence, palliative brachytherapy to relieve dysphagia gave a better quality of life as compared with SEMS in those with longer life expectancy, whereas SEMS were preferable for those with shorter life expectancy.4 However, palliative chemotherapy/chemoradiation can take several weeks to relieve dysphagia unlike SEMS, where the relief is almost immediate. Hence, one approach for those with longer life expectancy can be to place a FC-SEMS to rapidly relieve dysphagia and simultaneously start palliative chemotherapy or chemoradiation or brachytherapy. A few weeks later when palliative therapy takes effect, the SEMS can be removed to prevent delayed SEMS-related adverse events.5 This approach was used in a study by Shin et al, who showed a significant reduction in the incidence of adverse events and the need for re-interventions in those in whom the SEMS was removed after a few weeks during palliative radiotherapy as compared with those in whom the SEMS were not removed.6 PC-SEMS should not be used in anyone for whom there is a likelihood of removing the SEMS at a later date, as they can get embedded into the tissue ingrowth. They may be ideal for those with shorter life expectancy where stent removal is not required and one would not want to risk migration requiring re-intervention.

Abstract

BACKGROUND

Covered esophageal self-expandable metal stents (SEMSs) are currently used for palliation of malignant dysphagia. The optimal extent of the covering to prevent recurrent obstruction is unknown. Therefore, we aimed to compare fully covered (FC) versus partially covered (PC) SEMSs in patients with incurable malignant esophageal stenosis.

METHODS

In this multicenter randomized controlled trial, 98 incurable patients with dysphagia caused by a malignant stricture of the esophagus or cardia were randomized 1:1 to an FC-SEMS or PC-SEMS. The primary outcome was recurrent obstruction after endoscopic SEMS placement. Secondary outcomes were technical and clinical success, adverse events, and health-related quality of life (HRQoL). Patients were followed until 6 months after SEMS placement or to SEMS removal, second SEMS insertion, or death, whichever came first.

RESULTS

Recurrent obstruction after SEMS placement was similar for both types of stents: 19 % for FC-SEMSs and 22 % for PC-SEMSs (P = 0.65). The times to recurrent obstruction did not differ. The frequency of adverse events was similar between the two groups, with major adverse events occurring in 38 % and 47 % of patients for FC-SEMSs and PC-SEMSs, respectively (P = 0.34). No significant differences were seen in technical success, improvement of dysphagia, and HRQoL. Proximal esophageal stenosis and female sex were independently associated with recurrent obstruction and/or major adverse events.

CONCLUSIONS

Esophageal FC-SEMSs did not reveal a lower recurrent obstruction rate compared with PC-SEMSs in the palliative management of malignant dysphagia.

July 11th 2018

TAKE-HOME MESSAGE

Abstract

BACKGROUND & AIMS

As many as 45% of patients with gastroesophageal reflux disease (GERD) still have symptoms after receiving once-daily proton pump inhibitor (PPI) therapy. We aimed to compare reflux characteristics and patterns between responders and non-responders to once-daily PPI therapy using combined impedance-pH monitoring.

METHODS

Patients who reported heartburn and/or regurgitation at least twice per week for 3 months while receiving standard-dose PPI therapy were assigned to the PPI failure group (n=16). Patients who reported a complete resolution of symptoms on once-daily PPIs for at least 4 weeks were assigned to the PPI success group (n=13). We collected demographic data and subjects completed the short-form 36 and the GERD health-related quality of life questionnaires. Patients then underwent upper endoscopy and combined esophageal impedance-pH monitoring while on PPI therapy.

RESULTS

Four patients in the PPI success group (31%) and 4 patients in the PPI failure group (25%) had abnormal results from the pH test (P=1.00). Most of the patients in the PPI failure group (75%) were found to have either functional heartburn or reflux hypersensitivity with GERD. Impedance and pH parameters did not differ significantly between the PPI failure and success group.

CONCLUSION

We found no difference in reflux characteristics between patients with GERD who had successful vs failed once-daily PPI therapy. Most patients in the PPI failure group (75%) had functional esophageal disorders.

https://www.practiceupdate.com/journalscan/48019/2/9?elsca1=emc_enews_daily-digest&elsca2=email&elsca3=practiceupdate_gastro&elsca4=gastroenterology&elsca5=newsletter&rid=MzU0NzUwMjQyODcwS0&lid=10332481

April 2018

Esophageal atresia and tracheoesophageal fistula (EA/TEF) are relatively common malformations in newborns, but the etiology of EA/TEF remains unknown. Fanconi anemia (FA) complementation group A (FANCA) is a key component of the FA core complex and is essential for the activation of the DNA repair pathway. The middle region (amino acids 674-1208) of FANCA is required for its interaction with FAAP20. We performed targeted sequencing of this binding region of FANCA (exons 23-36) in 40 EA/TEF patients.

We also investigated the effect of the p.A958V mutation on the protein-protein interaction between FANCA and FAAP20 using an in vitro binding assay and co-immunoprecipitation. Immunolocalization analysis was performed to investigate the subcellular localization of FANCA, and tissue sections and immunohistochemistry were used to explore the expression of FANCA. We identified four rare missense variants in the FANCA binding region. FANCA mutations were significantly overrepresented in EA/TEF patients compared with 4300 control subjects from the NHLBI-ESP project (Fisher’s exact p = 2.17 × 10, odds ratio = 31.75). p.A958V, a novel de novo mutation in the FANCA gene, was identified in one patient with EA/TEF.

We provide further evidence that the p.A958V mutation reduces the binding affinity of FANCA for FAAP20. Interestingly, the p.A958V mutation impaired the nuclear localization of the FANCA protein expressed in HeLa cells. We found that FANCA was more highly expressed in stratified squamous epithelium than in smooth muscle. In conclusion, mutations in the FANCA gene are associated with EA/TEF in humans.

https://www.sciencedirect.com/science/article/pii/S0378111918303482