SX-ELLA biodegradable stent for benign oesophageal strictures: a systematic review and proportion meta-analysis.

BACKGROUND: This systematic review aimed to analyse the use of the SX-ELLA biodegradable stent (BDS) for benign oesophageal strictures through the assessment of clinical and technical success, differences in pre- and post-BDS insertion dysphagia scores, rates of stent migration, and safety. METHODS: A systematic review was reported according to PRISMA guidelines, with a prospectively registered protocol. The databases PubMed, Embase, SCOPUS, and ClinicalTrials.gov were searched up to March 2022. Studies assessing the use of the SX-ELLA BDS in adults with benign oesophageal strictures were included. A pooled data analysis was conducted to analyse the clinical and technical success associated with BDS use, rate of stent migration, and safety. RESULTS: Of the 1509 articles identified, 16 studies treating 246 patients were eligible for inclusion. BDS was clinically successful in 41.9% of cases (95% CI = 35.7 - 48.1%), defined as those who experienced complete symptom resolution following BDS insertion. Technical success was achieved in 97.2% of patients (95% CI = 95.1 - 99.3%). A pooled analysis concluded a decrease in mean dysphagia score of 1.8 points (95% CI = 1.68 - 1.91) following BDS insertion. Re-intervention was required in 89 patients (36.2%, 95% CI = 30.2 - 42.2%), whilst stent migration occurred in 6.5% of patients (95% CI = 3.4 - 9.6%). A total of 37 major clinical complications related to BDS insertion were reported (15.0%, 95% CI = 10.5 - 19.5%). CONCLUSION: The pooled data analysis demonstrates the high technical and moderate clinical success of the SX-ELLA biodegradable stent, supporting its use for benign oesophageal strictures in adults. However, greater evidence is required for more robust conclusions to be made in terms of success when compared to alternative methods of intervention, such as endoscopic dilation.

Assessment of long-term results of repeated dilations and impact of a scheduled program of dilations for refractory esophageal strictures: a retrospective case-control study.

INTRODUCTION: In patients with benign and refractory esophageal strictures (BES), repeating initial dilations in short intervals could be recommended, but little data are available to validate this strategy. Our aim was to evaluate long-term results of a scheduled program of repeated and sustained esophageal dilations in patients with refractory strictures. METHODS: Patients with BES requiring five or more dilations were retrospectively included and divided in two groups for analysis: a SCHEDULED group (SDG) where patients were systematically rescheduled for the 5 first dilations; ON-DEMAND group (ODG) where patients were dilated only in case of recurrence of the dysphagia. Comparison between SDG and ODG was done with a 1:1 matching analysis and etiology of stricture. Clinical success was defined as the absence of dysphagia for more than a year. RESULTS: 39 patients with refractory BES were included with post-operative stenosis in 51.2% and post-caustic injury 28.2%; 10 were in SDG and 29 in ODG. In overall analysis (39 patients), the follow-up was 64.4 ± 32 months, success rate was 79.5% and duration of treatment was 27.3 ± 20 months, and mean number of dilations was 11.7 per patient. The need for dilations decreased significantly after 18 months of treatment with an average of 0.56 dilations per semester. Self-expandable metallic stent insertion was associated with an increased rate of complications (5.9% vs 59.1% p = 0.001). In matched analysis (10 ODG vs 10 SDG patients), the duration of treatment was lower in SDG (18.8 vs 41.4 months, p = 0,032) with a higher probability of remission (survival analysis, Log-rank: p = 0,019) and the success rate did not differ between ODG and SDG patients (80% vs 90%; NS). CONCLUSION: Overall, long-term esophageal dilations resulted in a 79.5% success rate and the need for further dilatations decreased significantly in both groups after 18-month follow-up. A scheduled dilation program was associated with a higher probability of final success and lower treatment duration.

Valuing innovative endoscopic techniques: endoscopic suturing to prevent stent migration for benign esophageal disease.

BACKGROUND AND AIMS: Reimbursement often presents a significant barrier to widespread adoption of innovative endoscopic devices. We aimed to determine the value (defined as cost savings to a payer) of endoscopic suturing devices in preventing the migration of esophageal stents placed for benign esophageal diseases. METHODS: A decision-analytic model was constructed from a payer perspective evaluating fully covered metal stent placement for benign esophageal diseases (fistula, leak, perforation, or stricture) in a hospital outpatient setting. The model compared 2 strategies: endoscopic suturing to anchor the stent or no suture. Health care outcomes and costs were derived from published systematic reviews and national databases (U.S. Food and Drug Administration Manufacturer and User Facility Device Experience [MAUDE] for safety data; 2018 Medicare Physician Fee Schedule and Provider Utilization and Payment Data databases for reimbursement data). RESULTS: From a payer perspective, reimbursement for care increased by US$1487.98 without endoscopic suturing per patient, compared with US$621.06 with endoscopic suturing, to cover the risk of stent migration in addition to usual professional and facility reimbursement for stent placement. Thus, an average cost saving of US$866.92 per patient was achieved with endoscopic suturing to reduce stent migration risks. Cost savings associated with suturing ranged from US$147.48 to US$1586.36 per patient, based on the indication for the procedure in sensitivity analysis. Cost savings increased with higher rates of technical success in suture placement. CONCLUSIONS: Creating a defined reimbursement pathway for endoscopic suture fixation of a stent for the treatment of benign esophageal diseases appears to be justified from a payer perspective.

Office-based esophageal dilation in head and neck cancer: Safety, feasibility, and cost analysis.

OBJECTIVE: To review experience, safety, and cost of office-based esophageal dilation in patients with history of head and neck cancer (HNCA). METHODS: The medical records of patients undergoing esophageal dilation in the office were retrospectively reviewed between August 2015 and May 2017. Patients were given nasal topical anesthesia. Next, a transnasal esophagoscopy (TNE) was performed. If the patient tolerated TNE, we proceeded with esophageal dilation using Seldinger technique with the CRE™ Boston Scientific (Boston Scientific Corp., Marlborough, MA) balloon system. Patients were discharged directly from the outpatient clinic. RESULTS: Forty-seven dilations were performed in 22 patients with an average of 2.1 dilations/patient (range 1-10, standard deviation [SD] ± 2.2). Seventeen patients (77%) were male. The average age was 67 years (range 35-78 years, SD ± 8.5). The most common primary site of cancer was oral cavity/oropharynx (n = 10), followed by larynx (n = 6). All patients (100%) had history of radiation treatment. Four patients were postlaryngectomy. The indication for esophageal dilation was esophageal stricture and progressive dysphagia. All dilations occurred in the proximal esophagus. There were no major complications. Three focal, superficial lacerations occurred. Two patients experienced mild, self-limited epistaxis. One dilation was poorly tolerated due to discomfort. One patient required pain medication postprocedure. Office-based esophageal dilation generated $15,000 less in health system charges compared to traditional operating room dilation on average per episode of care. CONCLUSION: In patients with history of HNCA and radiation, office-based TNE with esophageal dilation appears safe, well-tolerated, and cost-effective. In a small cohort, the technique has low complication rate and is feasible in an otolaryngology outpatient office setting. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:2261-2267, 2018.

Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

INTRODUCTION: Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. AREAS COVERED: We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

Early complications after esophageal atresia repair: analysis of a German health insurance database covering a population of 8 million.

The treatment of esophageal atresia is not centralized in Germany. Therefore, high numbers of departments are involved. Data on the results of esophageal atresia repair from Germany are lacking. The aim of this study was to evaluate the early postoperative results after repair of esophageal atresia based on unbiased data of a German health insurance. We aimed to determine whether characteristics of the departments had an impact on outcome and compared the results from this study with the literature data from centers with a high caseload. Data of a German health insurance covering ∼10% of the population were analyzed. All patients who had undergone esophageal atresia repair from January 2007 to August 2012 were included. Follow-up data of 1 year postoperatively were analyzed. The potential impact of various characteristics of the treating surgical institutions was assessed. Results were compared with the latest international literature. Seventy-five patients with esophageal atresia underwent reconstructive surgery in 37 departments. The incidences of anastomotic leak (3%) and recurrent tracheoesophageal fistula (7%) were comparable with the literature (both 2-8%). Anastomotic stricture required dilatation in 57% of patients (mean 5.1 ± 5.6 dilatations) comparing unfavorably to most, but not all international reports. During 1-year follow-up, 93% of the patients were readmitted at least once (mean 3.9 ± 3.1 admissions). The incidence of complications did not correlate with any of the characteristics of the treating institutions such as academic affiliation, the number of consultants, beds, and preterm infants treated per year (all P > 0.05). Based on unbiased data, postoperative results after repair of esophageal atresia in Germany are comparable with recently published reports from international single centers. A correlation between the complication rate and characteristics of the treating institutions was not identified.

LEVEL OF THE GUALITY OF LIFE OF THE PATIENTS AFTER ESOPHAGOPLASTY ON THE BASIS OF GASTROINTESTINAL INDEX ASSESSMENT.

The article presents the interview results of 55 patients after esophagoplasty (30 cases - after esophagogastroplasty, 25 cases - after esophagoplasty) using questionnaire GIQLI. The authors came to conclusions about advantages of extirpation of esophagus with esopagogastroplasty compared with subtotal shunt esophagocoloplasty because of high rate of gastrointestinal index of the quality of life and their components in patients after esophagogastroplasty compared with results of patients after esophagoplasty. There was noted an expessed growth in the scales and rise of gastrointestinal index in patients who underwent esophagogastroplasty after 3 years of follow-up.

Techniques and principles of endoscopic treatment of benign gastrointestinal strictures.

PURPOSE OF REVIEW: The fundamental goal of treating any stenosis is luminal enlargement to ameliorate the underlying obstructive symptoms. Symptoms depend on the etiology and the site of the stricture and may include dysphagia, nausea and vomiting, abdominal pain, obstipation, or frank bowel obstruction. This article compares the various current technologies available for the treatment of gastrointestinal stenoses with regard to ease and site of application, patient tolerance, safety and efficacy data, and cost-benefit ratio. RECENT FINDINGS: Recent studies indicate that gastrointestinal dilation and stenting have evolved to a point at which in many if not most situations they can be the first line therapy and potentially the final therapy needed to treat the underlying condition. SUMMARY: Following techniques and principles in the management of gastrointestinal strictures would allow for the well tolerated and effective treatment of most patients with the tools currently available today.

Fluoroscopically guided balloon dilation of benign esophageal strictures: incidence of esophageal rupture and its management in 589 patients.

OBJECTIVE: The purpose of this article is to investigate the incidence and management of esophageal rupture caused by balloon dilation in patients with benign esophageal strictures. MATERIALS AND METHODS: Fluoroscopically guided esophageal balloon dilation was performed on 589 patients with benign esophageal strictures during an 18-year period. The strictures had a range of causes: postoperative anastomotic stricture, corrosive stricture, postradiation stricture, esophageal achalasia, esophageal reflux, congenital stricture, esophageal web, esophageal ulcer, medication fibrosis, chronic inflammation, and posttraumatic stricture (in descending order of frequency). Esophageal rupture was assigned to one of three categories: type 1 was intramural, type 2 was transmural with a contained leak, and type 3 was transmural with an uncontained mediastinal leakage. RESULTS: A total of 1421 procedures were performed in 589 patients, with each patient undergoing 1-29 procedures. The technical success rate was 99.8%, and the clinical success rate was 91.7%. Patients with corrosive stricture underwent the highest number of procedures (mean, 4.38 procedures). The incidence of esophageal rupture was 14.7%. All esophageal ruptures were detected immediately after the procedure. Most ruptures (98.6%) were types 1 and 2 and were successfully managed conservatively. Only 1.4% of the ruptures were type 3 and required active management. One of the type 3 ruptures was successfully treated with a retrievable covered stent. Two patients with type 3 ruptures (0.96% of ruptures) underwent surgery and were successfully treated. The rupture rate was not statistically related to the diameter of balloon used. CONCLUSION: The incidence of esophageal rupture after fluoroscopically guided esophageal balloon dilation was 14.7%. Almost all ruptures were type 1 or 2 and were successfully managed conservatively. Only 1.4% of the ruptures were type 3 and required active management. There was no procedure-related mortality in any patient. Therefore, in spite of the high incidence of ruptures, fluoroscopically guided balloon dilation is a safe procedure, particularly if a rupture is identified early and managed appropriately.

Late morbidity after colon interposition for corrosive esophageal injury: risk factors, management, and outcome. A 20-years experience.

OBJECTIVE: The aim of this study was to report our experience in the management of late morbidity after colonic interposition for caustic injury and to assess the influence of coloplasty dysfunction on patient outcome. SUMMARY BACKGROUND DATA: Reports on coloplasty dysfunction after colon interposition for corrosive esophageal injuries are scarce in the literature. Dysfunction of the colonic substitute might jeopardize an already fragile functional result, and appropriate management can improve outcome. METHODS: Long-term follow-up (>6 months) was conducted in 223 patients (125 men; median age, 35 years) who underwent colonic interposition for caustic injuries between 1987 and 2006. Statistical tests were performed on this cohort to identify risk factors for late morbidity and functional outcome. During the same period, 28 patients who underwent colon interposition for caustic injury in another center were referred for treatment of coloplasty dysfunction. Data from these patients were used together with those of our patients to describe specific coloplasty-related complications and their management. RESULTS: With a median follow-up of 5 years (range: 6 months-20 years), late complications were recorded in 125 (55%) of our patients (stenosis 36%, reflux 11%, redundancy 5%). A delay in reconstruction <6 months (P = 0.03) and absence of thoracic inlet enlargement (P = 0.002) were independent predictive factors for cervical anastomotic stenosis. Functional failure was recorded in 52 patients (23%) and was associated with a delay in reconstruction <6 months (P = 0.009) and emergency tracheotomy (P = 0.002). Coloplasty dysfunction was responsible for half of the recorded failures. Revision surgery for coloplasty dysfunction was performed in 96 patients (68 local, 28 referred) with an overall 70% success rate. CONCLUSIONS: Late complications occurred in half of the patients after colonic interposition for corrosive injuries and accounted for half of the functional failures. Prolonged surgical follow-up and appropriate management of coloplasty dysfunction are key factors for long-term success after esophageal reconstruction for caustic injuries.

Farming-related caustic ingestion by a 2-year-old: innocent play with costly results.

Young children continue to ingest caustic materials while playing in farm work areas. However, recent agricultural safety and health literature scarcely mentions caustic ingestion, and national incidence data specific to childhood caustic ingestion occurring on farms were not found. We present a case report of a 2-year-old child who, while playing with her brother, ingested dairy pipeline cleaner (an alkali). This case, although not unique, raises concerns about current prevention efforts related to the use and storage of chemicals on farms, long-term medical problems and associated costs, and the level of tolerance regarding the intermingling of innocent child play with adult work.

3D CT protocol in the assessment of the esophageal neoplastic lesions: can it improve TNM staging?

The purpose of this prospective observational study was the evaluation of the usefulness of MPR reconstructions and virtual endoscopy in the study of the esophageal carcinoma. Thirty-nine patients with esophageal cancer proved by means of endoscopy, underwent preoperative TNM staging with dynamic CT of the chest and abdomen with the aid of 3D rendering. Twenty-six patients underwent surgery, and the CT results were compared with histopathologic findings. In staging the T parameter, the CT with 3D reconstructions and virtual endoscopy, showed a sensitivity of 92% and an accuracy of 88%. In staging lymph nodes, the sensitivity in our study was 85%, the specificity 58%, and the accuracy 69%. Our protocol of the study of the esophageal cancer with 3D CT and virtual endoscopy, demonstrated a high concordance with the surgical and pathologic findings. The 3D reconstructed images were very helpful to the surgeons regarding preoperative planning. We performed an observational enquiry, and although this was a small study, it has, however, confirmed that the 3D imaging of the esophagus represents a valuable advantage to conventional imaging. Further studies with a larger number of patients are needed to prove its superiority to traditional CT imaging of the esophagus.

Cost-effectiveness of endoscopically placed stents in the palliation of locally advanced esophageal carcinoma.

The study assessed 50 consecutive patients presenting advanced esophageal carcinoma, in order to evaluate the cost-effectiveness of endoscopic palliation of dysphagia. Cases were divided into groups according to the type of therapy: Group A - surgical resections; Group B - gastrostomy, jejunostomy, surgical bypass or no palliation; Group C - endoscopic palliation. A retrospective study analysed early mortality, length of hospital stay and cost of therapy. Mean postoperative survival was within the expected limits in the endoscopically treated group (3-6 months), and in the non-resected group, while resected patients showed a very high early mortality and no long term survivals. Costs were significantly smaller in Group C as compared with Group A, with shorter hospital stay and better palliation. We conclude that endoscopically placed stents represent a cost effective palliation for advanced esophageal carcinoma and medical authorities should consider covering the expenses required by such procedures.

Different techniques for creating oesophageal anastomoses. A historical review and personal experience.

UNLABELLED: Among the surgical techniques used to create a reliable oesophageal anastomosis, mention should be made of the handmade (in one or two layers, wire or Vicryl) and the different stapler anastomoses. 41 oesophageal anastomoses were performed by stapler technique between 4 March 1985 and 4 March 1991. The EEA stapler was used in 15, and the SPTU stapler in 26 patients. The average age was 56.8 years overall, 53.6 in the female (7 patients) and 57.4 years in the 34 male patients. Tumours in the middle and lower third of the oesophagus and on the cardia were the indications for resection in 30 instances. Total gastrectomy was performed in 9 patients and oesophageal resection for peptic stricture in 2 cases. Replacement with stomach was carried out after oesophageal resection (17 patients), and with Roux-loop in 24 cases. The EEA anastomoses were not covered by a hand-made layer of interrupted sutures as is compulsory in the case of the SPTU gun. The intraoperative complication rate was 12.2%--two severe complications with the SPTU and 3 mild ones with the EEA (2 cases) and SPTU (1 case) machines. The postoperative complication rate was 17%--the severe ones with the SPTU gun. The only fatal anastomosis insufficiency was observed in this group. 3 of the 41 patients died--a mortality rate of 7.3%--but only one of them was due to technical failure in the SPTU group: 2.4%. CONSEQUENCES: Both the intra- and postoperative complications were more severe with the SPTU technique. The early postoperative complications are closely related to the intraoperative ones. Mortality due to technical failure was only observed in the SPTU group. The EEA stapler gun is superior in every respect to the SPTU sewing-machine. The future belongs to the even more sophisticated bent and modifiable devices. These were used in our Department Between 1992 and 1997, with practically no morbidity and no mortality. Although they are the most expensive of all the possibilities, the low morbidity and mortality rates pay off from the aspects of the short hospital stay and the savings in human life.

[Value of the esophagogram in preoperative assessment of esophageal carcinoma]. / Stellenwert des Osophagogramms bei der präoperativen Einschätzung des Osophaguskarzinoms.

PURPOSE: In this study we utilized barium swallows exhaustively in each patient. After that we compare the results with the intraoperative findings. The goal is to select those criteria which contribute to the preoperative clinical staging of esophageal carcinoma. METHODS: In a retrospective study we examined the esophagograms of 65 tumor patients. We evaluated the location and length of the tumor, the deformation of the esophageal axis, stenosis, dilatation, and the radiological type of the tumor. All characteristics were correlated with the pathologically determined TNM-criteria, the stage of the tumor, and the palliative or curative type of resection. RESULTS: We found the following significant correlations: localisation/T-criterion, radiological type/T-and M-criteria, stenosis/type of resection, deformation of the axis, stenosis and radiological type/tumor stage. CONCLUSION: In the sense of a checklist the stenosis, the deformation of the esophageal axis and the radiological type of the tumor should be carefully evaluated and included in the report. With these data, the clinical stage of the tumor can be estimated.

Outpatient management of esophageal cancer with endoscopic Nd:YAG laser.

In 50 inoperable patients with advanced malignant obstruction of the esophagus, endoscopic Nd:YAG laser treatment was used for palliation of dysphagia. In 30 of these patients, treatment was carried out entirely in an outpatient setting, providing more time at home and saving costs of hospitalization. Most patients had received prior radiation and chemotherapy. All were unable to swallow solid food; 16 had difficulty with liquids. Palliation was achieved in 69% allowing patients to eat a nearly normal diet. Therapy was least successful in cancers involving the cervical esophagus, in cancers more than 8 cm in length, and in cancers that were primarily infiltrating or extraluminal. Epidermoid carcinomas and adenocarcinomas were effectively treated, except for adenocarcinomas of the gastric cardia, which tended to be infiltrating. There were two serious but nonfatal complications, one perforation and one episode of bleeding, directly attributable to Nd:YAG laser therapy. An esophageal dilation prior to endoscopic Nd:YAG laser treatment facilitated outpatient management.

Intraoperative assessment of intestinal viability with Doppler ultrasound.

Following preliminary experimental animal studies showing Doppler ultrasound to be reliable in predicting intestinal viability and to correlate well with subserosal thermistor thermometry measurements, the Doppler technique has been used clinically for intraoperative intestinal viability assessment in colon-esophageal bypasses and colonic resections. Our clinical experience has shown Doppler ultrasound to be far superior to traditional predictive criteria. The presence of good Doppler sounds confirms adequate collateral pulsatile blood flow ensuring viability of the intestinal segment, whereas the absence of Doppler sounds indicates the need for appropriate revascularization. Based on the reliability of Doppler ultrasound, its simple technique and its relative inexpensiveness, we recommend the routine use of Doppler ultrasound for the evaluation of the quality and adequacy of intestinal blood flow in predicting the viability of a segment of the intestine.