ABSTRACT
Background and study aims Dysphagia from esophageal cancer may be palliated with self-expanding metallic stents (SEMS). Controversy exists about the use of dilation before SEMS deployment. Patients and methods We performed a retrospective cohort study of patients who had SEMS placement without fluoroscopy for palliation at Tenwek Hospital in Bomet, Kenya between January 1999 and April 2019. The primary outcome was any serious adverse event (AE) (chest pain, stent migration, perforation, bleeding, or all-cause mortality) within 30 days of the procedure. Various demographic and clinical characteristics, and procedural details, were examined as risk factors. Technical success, defined as correct SEMS placement, and clinical success, defined as dysphagia score improvement without 30-day mortality, were examined. Results A total of 3823 patients underwent SEMS placement, with 2844 (74.4â%) placed in the second decade of the study. Technical and clinical success were achieved in 97.2â% and 95.5â%, respectively, with mean dysphagia scores improving from 3.4 (SD 0.6) to 0.9 (SD 1.3) post-stent placement. AEs occurred in 169 patients (4.4â%). AEs, specifically perforations, were associated with dilation to greater than 36F in the first decade. Perforation rates decreased from the first (4.1â%) to the second decade (0.2â%). Only 30% had complete 30-day follow-up data. Conclusions SEMS placement is a safe, effective method of palliating malignant dysphagia, with low rates of AEs and 30-day mortality and high rates of clinical and technical success. Dilation can facilitate placement of SEMS without fluoroscopy but should not be performed above 36F due to the risk of perforation.
ABSTRACT
BACKGROUND: Esophageal squamous cell carcinoma (ESCC) is a major cause of cancer morbidity and mortality in Eastern Africa. The majority of patients with ESCC in Eastern Africa present with advanced disease at the time of diagnosis. Several palliative interventions for ESCC are currently in use within the region, including chemotherapy, radiation therapy with and without chemotherapy, and esophageal stenting with self-expandable metallic stents; however, the comparative effectiveness of these interventions in a low resource setting has yet to be examined. METHODS: This prospective, observational, multi-center, open cohort study aims to describe the therapeutic landscape of ESCC in Eastern Africa and investigate the outcomes of different treatment strategies within the region. The 4.5-year study will recruit at a total of six sites in Kenya, Malawi and Tanzania (Ocean Road Cancer Institute and Muhimbili National Hospital in Dar es Salaam, Tanzania; Kilimanjaro Christian Medical Center in Moshi, Tanzania; Tenwek Hospital in Bomet, Kenya; Moi Teaching and Referral Hospital in Eldoret, Kenya; and Kamuzu Central Hospital in Lilongwe, Malawi). Treatment outcomes that will be evaluated include overall survival, quality of life (QOL) and safety. All patients (≥18 years old) who present to participating sites with a histopathologically-confirmed or presumptive clinical diagnosis of ESCC based on endoscopy or barium swallow will be recruited to participate. Key clinical and treatment-related data including standardized QOL metrics will be collected at study enrollment, 1 month following treatment, 3 months following treatment, and thereafter at 3-month intervals until death. Vital status and QOL data will be collected through mobile phone outreach. DISCUSSION: This study will be the first study to prospectively compare ESCC treatment strategies in Eastern Africa, and the first to investigate QOL benefits associated with different treatments in sub-Saharan Africa. Findings from this study will help define optimal management strategies for ESCC in Eastern Africa and other resource-limited settings and will serve as a benchmark for future research. TRIAL REGISTRATION: This study was retrospectively registered with the ClinicalTrials.gov database on December 15, 2021, NCT05177393 .
