B/F/TAF forgiveness to non-adherence.

BACKGROUND: ART forgiveness is the ability of a regimen to maintain HIV-RNA suppression despite a documented imperfect adherence. We explored forgiveness of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). METHODS: In this retrospective cohort study pharmacy drug refills were used to calculate the proportion of days covered (PDC) as a proxy of adherence. Forgiveness was defined as the possibility to achieve a selected HIV-RNA threshold by a given level of imperfect adherence. A logistic model was applied to verify the impact of baseline variables and adherence on the virologic outcomes. RESULTS: We enrolled 420 adults. From them, 787 one-year time-periods were derived for a median cohort follow-up of 873 person/years.Most of them were males (73.1%); the most frequent risk factor for HIV infection was heterosexual contacts (49.5% of cases), followed by 22.5% MSM and 22.5% intravenous drug users. The median age of enrolled persons with HIV was 51 years (IQR 45-57 years); the median duration of HIV infection was 7.9 years (IQR 4-18 years) and the median nadir of CD4 cells was 277 cells/mcL (IQR 100-513 cells/mcL).Adherence showed a median of 0.97 (IQR 0.91-1.00), consequently only 17 time-periods (2.2%) in 17 different individuals (4.0%) showed HIV-RNA blood levels above 200 copies/ml.A PDC of 0.75 was sufficient to obtain in > 90% of cases the virologic outcome for both 200 copies/ml or 50 copies/ml. An adherence value of 0.85 obtained a positive response in virtually all subjects either for a cut-off of 50 or 200 copies/ml. CONCLUSIONS: Long-term success of ART needs effective, well tolerated, friendly regimens. Adherence remains a crucial determinant of long-term success, but suboptimal adherence levels are relatively common. Given this, an elevated forgiveness plays a relevant role to further improve long-term outcomes and should be considered a fundamental characteristic of any antiretroviral regimen. B/F/TAF has been proved to have all of these characteristics.

A new designed self-expandable metal stent for the management of benign radiotherapy-induced hypopharyngeal or cervical esophageal strictures.

BACKGROUND AND AIMS: The management of patients with hypopharyngeal or cervical esophageal refractory benign strictures (RBS) after surgery and radiotherapy ± chemotherapy for laryngeal cancer is challenging. We aimed to assess the long-term efficacy and safety of a new designed fully covered SEMS in these patients. METHODS: We reviewed the results of a prospectively collected database of 40 consecutive patients with dysphagia due to RBS of the cervical esophagus or hypopharynx after surgery and radiotherapy with or without chemotherapy for laryngeal cancer, unfit for surgery, referred in two tertiary-care endoscopic centers from June 2005 to December 2018. All of them were treated with placement of a Niti-S Conio cervical stent. RESULTS: After placement of the first stent, dysphagia improved in all patients. The total number of adverse events was 35 out of a total of 299 procedures (11.7%): 25 (8.4%) stent migrations, 6 (2%) tumor overgrowth, 3 severe pain and 1 pharyngo-cutaneous fistula. Stents were periodically changed. In only one patient with a cervical esophageal stricture the stent was definitively removed after 7 sessions of stent placement because of stricture resolution. Patients were followed-up for a median of 11.6 months and a significant improvement in dysphagia was reported in all patients (p < 0.001). CONCLUSIONS: The use of this conformable, small caliber new designed Niti-S stent, exchanged periodically, appeared safe and permitted durable oral intake in patients with difficult-to-treat hypopharyngeal or cervical esophagus strictures, avoiding the need for periodic dilations.

Dietary Habits and Risk of Esophagitis and Barrett's Esophagus: A Multicenter Italian Case-Control Study.

BACKGROUND: Barrett's esophagus (BE) and esophagitis share potentially modifiable risk factors such as obesity, smoking, and alcohol. The role of diet on BE and esophagitis is still debated. AIMS: The objective of this study was to examine the association between some dietary habits and the risk of BE and esophagitis in Italy. METHODS: A multicenter case-control study involving 1285 individuals was carried out in 12 areas. Patients with a new diagnosis of BE (320) or esophagitis (359) and a group of endoscopic controls (606) were included. Information on personal history and dietary habits was collected using a structured questionnaire. RESULTS: No clear monotonic significant dose-response relationship was found for most of the considered food items. Nevertheless, the most extreme consumption category of red meat, cold cuts, dairy products, and fried foods showed esophagitis risk excesses varying from 19 to 49%. A higher fat rich diet seemed to increase risk by 49% for BE and 94% for esophagitis. A downward tendency in esophagitis (- 27%) and BE risk (- 20%) was found associated with higher frequency of fresh fruit intake. In addition, a statistically significant twofold increased risk for both BE and esophagitis was found for subjects eating late evening snacks more than once every three days in comparison with the lowest intake category (no consumption). CONCLUSIONS: BE and esophagitis patients appeared to be more likely than controls to follow a diet rich in fats and poor in fruit and vegetables. Late evening snacks were found to be associated with both disorders.

Alcohol consumption pattern and risk of Barrett's oesophagus and erosive oesophagitis: an Italian case-control study.

Knowledge about the association between alcohol and Barrett's oesophagus and reflux oesophagitis is conflicting. In this case-control study we evaluated the role of specific alcoholic beverages (red and white wine, beer and liquors) in 339 Barrett's oesophagus and 462 oesophagitis patients compared with 619 endoscopic controls with other disorders, recruited in twelve Italian endoscopic units. Data on alcohol and other individual characteristics were obtained from structured questionnaires. No clear, monotonic significant dose-response relationship was pointed out for red wine. However, a generalised U-shaped trend of Barrett's oesophagus/oesophagitis risk due to red wine consumption particularly among current drinkers was found. Similar results were also found for white wine. Liquor/spirit consumption seemed to bring about a 1·14-2·30 risk excess, although statistically non-significant, for current Barrett's oesophagus/oesophagitis drinkers. Statistically significant decreasing dose-response relationships were found in Barrett's oesophagus for frequency and duration of beer consumption. Similar, but less clear downward tendencies were also found for oesophagitis patients. In conclusion, although often not statistically significant, our data suggested a reduced risk of Barrett's oesophagus and oesophagitis with a low/moderate intake of wine and beer consumption. A non-significant increased risk of Barrett's oesophagus/oesophagitis was observed with a higher intake of any type of heavy alcohol consumption, but no conclusion can be drawn owing to the high number of non-spirit drinkers and to the small number of drinkers at higher alcohol intake levels.

Smoking as an independent determinant of Barrett's esophagus and, to a lesser degree, of reflux esophagitis.

PURPOSE: To evaluate the role of smoking in Barrett's esophagus (BE) and erosive esophagitis (E) compared to endoscopic controls with no BE or E. Smoking is considered a cause of both BE and E, but results on this topic are quite controversial. METHODS: Patients with BE (339), E (462) and controls (619: 280 with GERD (gastroesophageal reflux disease)-negative and 339 with GERD-positive anamnesis) were recruited in 12 Italian endoscopy units. Data were obtained from structured questionnaires. RESULTS: Among former smokers, a remarkable upward linear trend was found in BE for all smoking-related predictors. In particular, having smoked for more than 32 years increased the risk more than two times (OR 2.44, 95 % CL 1.33-4.45). When the analysis was performed in the subgroup of subjects with GERD-negative anamnesis, the risk of late quitters (<9 years) passed from OR 2.11 (95 % CL 1.19-3.72) to OR 4.42 (95 % CL 1.52-12.8). A noticeably positive dose-response relationship with duration was seen also among current smokers. As regards E, no straightforward evidence of association was detected, but for an increased risk of late quitters (OR 1.84, 95 % CL 1.14-2.98) in former smokers and for early age at starting (OR 3.63, 95 % CL 1.19-11.1) in GERD-negative current smokers. CONCLUSIONS: Smoking seems to be an independent determinant of BE and, to a lesser degree, of E. The elevation in risk is independent from GERD and is already present in light cigarette smokers. Smoking cessation may reduce, but not remove this risk.

Weight Gain in Overweight and Obese People with HIV-The OBHIV Cohort.

BACKGROUND: HIV and non-HIV-related factors have been related to weight gain (WG); however, their specific impact on people with HIV (PWH) who are overweight or obese remains unclear. METHODS: This is a single-center observational study enrolling PWH with a BMI > 25 kg/m2. A generalized linear model was used to assess variables related to greater WG during 12 years of observation. RESULTS: A total of 321 PWH were enrolled, 67% overweight and 33% obese, who gained an average of 0.2 ± 1.3 and 1.7 ± 1.5 kg/year, respectively (p < 0.0001). Years since HIV infection were the only variable significantly associated with WG (ß -0.048, 95% CI -0.083; -0.013) during the study period, while type of ART did not influence the outcome. Narrowing the observation to the period of the SARS-CoV-2 pandemic, PWH with a longer duration of infection (ß 0.075, 95% CI 0.033; 0.117) and a greater increase in triglycerides (ß 0.005; 95% CI 0.000; 0.011) gained more weight, while higher BMI (ß -0.256, 95% CI -0.352; -0.160), obesity (ß -1.363, 95% CI -2.319; -0.408), diabetes mellitus (ß -1.538, 95% CI -2.797; -0.278), and greater abdominal circumference (ß -0.086, 95% CI -0.142; -0.030) resulted in protection. CONCLUSION: Among overweight and obese PWH, the amount of WG was higher in the first years after diagnosis of HIV and decreased thereafter, despite aging, regardless of the type of ART.

Elevations in alanine aminotransferase levels late in the course of antiviral therapy in hepatitis C virus RNA-negative patients are associated with virological relapse.

UNLABELLED: The incidence and clinical meaning of elevated alanine aminotransferase (ALT) in chronic hepatitis C patients who are hepatitis C virus (HCV)-RNA negative during pegylated interferon (PEG-IFN) and ribavirin therapy have not been completely characterized. In this study our aim was to assess the incidence, pattern, predictive factors, and clinical meaning of elevated ALT in a cohort of 173 chronic hepatitis C patients who obtained viral clearance during either PEG-IFNalpha2(a) or alpha2(b) and weight-based ribavirin therapy. Patients were defined sustained viral responders (SVRs) or relapser responders (RRs) on the basis of a serum HCV-RNA result at 24-week follow-up. SVR and RR were obtained in 141 (58%) and 32 patients (13%), respectively. Among the 173 study patients, 57 patients (33%) had undetectable serum HCV-RNA and elevated ALT in at least one evaluation (weeks 2, 4, 12, 24 in all genotypes, and week 48 in HCV genotype 1 and 4 alone), and this phenomenon was not differently distributed between SVRs and RRs. No pretreatment demographic (age, gender), clinical (ALT levels, histological grade and stage, body mass index) and viral (load, genotype) parameter was associated with this phenomenon. The incidence of elevated ALT levels was not associated with type of PEG-IFN and ribavirin dose. Elevated ALT levels showed a different longitudinal pattern, occurring more frequently between week 12 and the end of treatment in RR as compared to SVR patients (90% versus 9%, P = 0.000001). CONCLUSION: The occurrence of elevated ALT levels in HCV-RNA-negative patients during PEG-IFN and ribavirin therapy is a fairly frequent and unpredictable phenomenon. Although ALT elevation per se is not associated with a greater risk of relapse, its occurrence in the later phases of therapy is more common in relapsing patients.

Endoscopic management of GI perforations with a new over-the-scope clip device (with videos).

BACKGROUND: Through-the-scope endoclips have been used to manage small perforations in the GI tract, but they have limitations. A new over-the-scope clip system, OTSC (Ovesco Endoscopy, Tuebingen, Germany), may be suitable for the closure of larger GI leaks. OBJECTIVE: To evaluate the clinical outcomes of patients with GI perforations of up to 20 mm, treated with OTSC. DESIGN: Prospective, single-arm, pilot study. SETTING: General hospitals referral centers for endotherapy. PATIENTS: This study involved 10 patients (median age 58.5 years [range 27-82 years], 7 men) with GI leaks from perforations, fistulas, and anastomotic dehiscence. Two gastric, 2 duodenal, and 6 colonic leaks were treated with OTSC. The diameter of leaks ranged between 7 and 20 mm. INTERVENTIONS: OTSC devices were used to seal the GI leaks. Then Gastrografin (Bayer AG, Germany) was introduced via the endoscope and complete sealing confirmed under fluoroscopy. Patients underwent a second endoscopic examination 3 months later. MAIN OUTCOME MEASUREMENT: Complete sealing of the leak. RESULTS: Complete sealing of leaks was achieved by using OTSC alone in 8 of 10 patients. For one patient, successful endoscopic management was completed by placing two additional covered stents. Only one patient required surgical repair of the leak. Endoscopic examination 3 months after treatment confirmed that leaks in 8 of 9 endoscopically treated patients were healed, and the patients did not have recurrence of the leaks or complications from the OTSC devices. One patient died from neoplastic progression before the second endoscopy could be performed. LIMITATIONS: Uncontrolled study. CONCLUSIONS: The OTSC system appears to be a useful device in the management of larger GI leaks in a variety of clinical scenarios.

Cap-assisted endoscopic mucosal resection for colorectal polyps.

PURPOSE: Cap-assisted endoscopic mucosal resection has been used to treat superficial esophageal and gastric cancers. Efficacy data in the colon are limited. The aim of the study was to evaluate the safety and efficacy of this technique in the treatment of sessile polyps and lateral spreading tumors in the colorectum. METHODS: Two-hundred and fifty-five consecutive patients with sessile polyps or lateral spreading tumors >or=20 mm were treated between January 2000 and December 2007. RESULTS: A total of 146 sessile polyps and 136 lateral spreading tumors were treated with cap-assisted endoscopic mucosal resection. Complications occurred in 22 (8.6%) patients (5.5% in sessile polyps and 10.3% in lateral spreading tumors). Intraprocedural bleeding occurred in 21 (7%) of polypectomies (6% in sessile polyps and 10% in lateral spreading tumors); all were controlled endoscopically. Postcoagulation syndrome occurred in 1 patient with lateral spreading tumor. No perforation occurred. Invasive adenocarcinoma was found in 35 patients, of whom 15 underwent surgery. Endoscopic follow-up in 200 patients with 216 adenomas for a median of 12.1 months showed recurrence in 8 (4%) who were treated with resection and/or ablation. CONCLUSIONS: Cap-assisted endoscopic mucosal resection is an effective treatment for sessile polyps and lateral spreading tumors. A disadvantage of the technique is that the resection is piecemeal. Close surveillance provides the opportunity for additional tissue ablation, when required, to achieve complete lesion removal.

Acute small bowel obstruction caused by endometriosis: a case report and review of the literature.

Gastrointestinal involvement of endometriosis has been found in 3%-37% of menstruating women and exclusive localization on the ileum is very rare (1%-7%). Endometriosis of the distal ileum is an infrequent cause of intestinal obstruction, ranging from 7% to 23% of all cases with intestinal involvement. We report a case in which endometrial infiltration of the small bowel caused acute obstruction requiring emergency surgery, in a woman whose symptoms were not related to menses. Histology of the resected specimen showed that endometriosis was mainly prevalent in the muscularis propria and submucosa and that the mucosa was not ulcerated but had inflammation and glandular alteration. Endometrial lymph node involvement, with a cystic glandular pattern was also detected.

Polyflex stents for malignant oesophageal and oesophagogastric stricture: a prospective, multicentric study.

OBJECTIVE: Dysphagia is the most distressing symptom in patients with cancer-related oesophageal obstruction. Endoscopic palliation aims to restore swallowing, avoid reintervention and to reduce hospitalization. This study reports an experience with a new self-expandable plastic stent (Polyflex) in patients with unresectable oesophageal and oesophagogastric junction cancer. METHODS: Sixty patients were prospectively collected. The cause of obstruction was oesophageal squamous cell carcinoma (44) and adenocarcinoma (eight), lung cancer (seven) and thyroid tumour (one). RESULTS: The stent was successfully placed in 59 patients. Early minor complications occurred in 19 patients (32%), and major complications in 13 (22%). Death occurred in three patients owing to pulmonary embolism (one) and massive haemorrhage (two). Recurrent dysphagia for early stent migration was observed in seven patients. Delayed stent migration occurred in five patients and tumour overgrowth in eight patients. The mean dysphagia score of 2.8 improved to a mean score of 1.0 after stenting (P<0.001). Overall median survival time was 4.6 months. CONCLUSIONS: Our study suggests that Polyflex stents are competitive with metal stents, with similar efficacy but lower cost. Technical improvements, however, are required to make these stents more user friendly. Large randomized clinical studies are needed to guide in the choice among the different available stents.

Endoscopic mucosal resection of large hyperplastic polyps in 3 patients with Barrett's esophagus.

AIM: To report the endoscopic treatment of large hyperplastic polyps of the esophagus and esophago-gastric junction (EGJ) associated with Barrett's esophagus (BE) with low-grade dysplasia (LGD), by endoscopic mucosal resection (EMR). METHODS: Cap fitted EMR (EMR-C) was performed in 3 patients with hyperplastic-inflammatory polyps (HIPs) and BE. RESULTS: The polyps were successfully removed in the 3 patients. In two patients, with short segment BE (SSBE) (<= 3 cm), the metaplastic tissue was completely excised. A 2 cm circumferential EMR was performed in one patient with a polyp involving the whole EGJ. A simultaneous EMR-C of a BE-associated polypoid dysplastic lesion measuring 1 cm multiply 10 cm, was also carried out. In the two patients, histologic assessment detected LGD in BE. No complications occurred. Complete neosquamous re-epithelialization occurred in the two patients with SSBE. An esophageal recurrence occurred in the remaining one and was successfully retreated by EMR. CONCLUSION: EMR-C appears to be a safe and effective method for treating benign esophageal mucosal lesions, allowing also the complete removal of SSBE.

Endoscopic mucosal resection for high-grade dysplasia and intramucosal carcinoma in Barrett's esophagus: an Italian experience.

AIM: To evaluate endoscopic mucosal resection (EMR) in patients with high-grade dysplasia (HGD) and/or intramucosal cancer (IMC) in Barrett's esophagus (BE). METHODS: Between June 2000 and December 2003, 39 consecutive patients with HGD (35) and/or IMC (4) underwent EMR. BE >30 mm was present in 27 patients. In three patients with short segment BE (25.0%), HGD was detected in a normal appearing BE. Lesions had a mean diameter of 14.8+/-10.3 mm. Mucosal resection was carried out using the cap method. RESULTS: The average size of resections was 19.7+/-9.4 x 14.6+/-8.2 mm. Histopathologic assessment post-resection revealed 5 low-grade dysplasia (LGD) (12.8%), 27 HGD (69.2%), 2 IMC (5.1%), and 5 SMC (-12.8%). EMR changed the pre-treatment diagnosis in 10 patients (25.6%). Three patients with SMC underwent surgery. Histology of the surgical specimen revealed 1 T0N0 and 2 T1N0 lesions. The remaining two patients were cancer free at 32.5 and 45.6 mo, respectively. A metachronous lesion was detected after 25 mo in one patient with HGD. Intra-procedural bleeding, controlled at endoscopy, occurred in four patients (10.3%). After a median follow-up of 34.9 mo, all patients remained in remission. CONCLUSION: In the medium term, EMR is effective and safe to treat HGD and/or IMC within BE and is a valuable staging method. It could become an alternative to surgery.

Barrett's esophagus: an update.

Barrett's esophagus (BE) is a complication observed in a small subset of patients with chronic gastroesophageal reflux. It is characterized by the presence of intestinal-type goblet cells in biopsies from the lower esophagus. The prevalence of BE increases with age, affecting 1% of the population older than 60 years. A genetic predisposition to reflux disease has been proposed. In a twin study of reflux disease, concordance was greater in monozygotic than dizygotic twins. An association between BE and esophageal adenocarcinoma, the incidence of which has increased remarkably in the last few decades, has been established. Esophagogastric junction cancers can arise from small areas of cardia intestinal metaplasia (CIM). Regular endoscopic and histologic follow-up of BE patients is recommended. Surveillance of patients with CIM is not advised. Chromoendoscopy may help to detect areas of high-grade dysplasia (HGD). The ablation of BE, e.g. by PDT or argon plasma coagulation, is not yet proven to reduce the cancer risk. Esophagectomy is still the standard management of HGD. Endoscopic mucosal resection may be used for visible, localized lesions with HGD, and this technique may be combined with thermal ablation for areas of HGD without visible abnormality.

One-step circumferential endoscopic mucosal cap resection of Barrett's esophagus with early neoplasia.

BACKGROUND AND OBJECTIVE: Focal endoscopic mucosal resection (EMR) of visible intraepithelial lesions arising within Barrett's esophagus (BE) may miss synchronous lesions that are not endoscopically apparent. Stepwise radical endoscopic resection would obviate this concern by removing all BE; however, it requires repeated endoscopy which may increase the risk of complications, particularly for patients with circumferential BE. The aim of the study was to evaluate the safety and efficacy of one-step complete circumferential resection of BE by cap-assisted EMR (EMR-C) among patients with circumferential BE and high-grade dysplasia or intramucosal carcinoma. PATIENTS AND METHODS: Between January 2003 and March 2010, 47 patients with circumferential BE and biopsy-proven high-grade dysplasia or intramucosal cancer underwent EMR-C. We evaluated: (1) complete eradication of neoplasia, (2) complete eradication of metaplasia, and (3) complications including bleeding and esophageal stricture. RESULTS: Complete eradication of neoplasia and complete eradication of metaplasia were achieved after a median follow-up of 18.4 months in 91% (43/47) of patients. After EMR-C, two patients (one IMC, one invasive cancer) underwent esophagectomy. Histology of the resected specimens showed no residual disease and a T1bN0 lesion, respectively. Two patients had progression of neoplasia. A stenosis occurred in 18 out of 45 patients (40%). All stenoses were treated with dilations and two required temporary placement of a covered stent. CONCLUSION: One-step complete EMR-C is a safe and effective technique which can be considered in patients with early neoplastic lesions. Although 40% of patients developed dysphagia, this could well be managed endoscopically.

Full thickness endoscopic resection of a colonic cancer: a case report.

We present a case of a 40-year-old woman, diagnosed with a flat lesion (type 0-IIa+IIc) of the colon. There was a strong suspicion for submucosal invasion, however the patient initially refused surgical intervention. Therefore, the lesion was treated with full-thickness endoscopic resection. An over-the-scope clip device was applied to seal the resulting colonic wall defect. Histological examination demonstrated a T2 adenocarcinoma, therefore the patient agreed to a left hemicolectomy. Examination of the surgical specimen demonstrated no residual neoplasia or involvement of adjacent lymph nodes. We discuss the potential advantages and limitations of this new approach, which may be indicated for patients who are not surgical candidates.

History of cancer in first degree relatives of Barrett's esophagus patients: a case-control study.

BACKGROUND AND OBJECTIVE: Familial clusters of Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) have been reported. This study evaluates the history of cancer in BE patients families. METHODS: In two years, patients with BE (272), esophagitis (456) and controls (517) were recruited in 12 Italian Endoscopy Units. Cancer family history in first-degree (FD) relatives was determined by a questionnaire. RESULTS: Approximately 53% of BE, 51% of esophagitis, and 48% of controls had at least one relative affected by any type of malignancy. Probands with at least one esophageal or gastric (E/G) cancer-affected relative showed a BE risk which was at least eighty-five percent higher than that of probands without affected relatives. The relative risk of BE was 4.18, 95% CL=0.76-23.04 if a FD relative had early (mean age ≤ 50 years) onset E/G cancer compared to late onset E/G cancer. CONCLUSION: In this sample there was no evidence that a family history of cancer was associated with the diagnosis of BE. An intriguing result was the association between the occurrence of E/G cancers at earlier ages (< 50 years) among BE relatives with respect the control group. This could suggest a genetic contribution in onset of these tumors, but the sample was too small to demonstrate a significant association. Further exploration of family history of E/G cancer and a diagnosis of BE in larger samples is warranted.

The role of chromoendoscopy in the surveillance of the duodenum of patients with familial adenomatous polyposis.

Adenomas of the duodenum have been described in patients with familial adenomatous polyposis (FAP). Patients with FAP are at high risk for the development of periampullary cancer. The aim of our study was to evaluate if endoscopic visualization of small polyps, often overlooked at standard endoscopic examination, was improved by chromoendoscopy. Ten patients with FAP and previous colectomy underwent upper gastrointestinal endoscopy. Two skilled endoscopists were involved for each endoscopy. Evaluation of number and diameter of polyps was made before and after staining. After staining we detected a larger number of duodenal polyps than found at the standard endoscopic examination, the difference being statistically significant. This result seems to suggest that chromoendoscopy may improve diagnostic yield of endoscopy. Further studies are needed to suggest the best surveillance program and the appropriate therapeutic modality for these patients.

A modified self-expanding Niti-S stent for the management of benign hypopharyngeal strictures.

BACKGROUND: The management of patients with refractory hypopharyngeal strictures after surgery in combination with radiation therapy is disappointing, and nutrition through feeding tubes is often required. OBJECTIVE: To evaluate the efficacy and safety of a modified self-expanding Niti-S metal stent in the treatment of hypopharyngeal strictures after combined therapy for laryngeal cancer. DESIGN: Case series. SETTING: A general hospital and a university hospital. PATIENTS: Seven consecutive patients were included. One of them did not have laryngectomy. INTERVENTIONS: All patients received a modified Niti-S stent. MAIN OUTCOME MEASUREMENTS: Improvement of dysphagia, avoiding periodic bougienage, and enteral nutrition through feeding tubes. RESULTS: After placement of the first stent, dysphagia improved in all patients. Six of 7 patients developed stent migration and/or granulomatous tissue ingrowth or overgrowth. Additional stents were placed in all patients after a median of 3 months after the previous stent placement. One patient developed an esophagorespiratory fistula caused by a Polyflex stent. Two patients died of causes unrelated to the stent. The remaining 5 patients remained alive and asymptomatic after a median follow-up of 10 months. LIMITATIONS: Periodic stent exchange. Stent placement did not resolve the stricture definitively. We had a limited number of patients and have no long-term outcome data yet. CONCLUSIONS: The use of this modified Niti-S stent avoids both enteral nutrition through feeding tubes and the need for periodic bougienage in patients with difficult-to-treat benign hypopharyngeal strictures.

A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia.

OBJECTIVES: Self-expanding metal stents (SEMS) provide effective palliation in patients with malignant dysphagia, although severe complications and mortality may result. We performed a prospective controlled trial to compare a new self-expanding polyester mesh stent (Polyflex) with SEMS (Ultraflex). METHODS: One hundred one patients with unresectable esophageal carcinoma were randomized to placement of a Polyflex (N=47) or a partially covered Ultraflex (N=54) stent. Patients with esophagogastric junction (EGJ) malignancy were excluded. RESULTS: Placement was successful in 46 (98%) patients with the Polyflex and 54 (100%) patients with the Ultraflex stent. In one patient, the Polyflex stent could not be placed. After 1 wk, dysphagia was improved by at least 1 grade in 100% of the Polyflex group and in 94% of the Ultraflex group. Major complications were observed in 48% of the Polyflex group and 33% of the Ultraflex group. Intraprocedural perforation occurred in 1 Polyflex and 1 Ultraflex patient. Two Polyflex patients had postprocedural hemorrhage. Twenty (44%) patients with a Polyflex stent and 18 (33%) with an Ultraflex stent had recurrent dysphagia because of tumor overgrowth, stent migration, hyperplastic granulomatous reaction, or food bolus impaction. Multivariate analysis showed a significantly higher complication rate with Polyflex than with Ultraflex stents (odds ratio 2.3, 95% CI 1.2-4.4). However, median survival was 134 days with Polyflex and 122 days with Ultraflex stents (P=NS). CONCLUSIONS: No difference was seen in palliation of dysphagia between the two stents. Significantly more complications, especially late stent migration, were observed in the Polyflex group.