Squamous cell carcinoma of the esophagus with residual cancerous stricture after CRT/RT, unresectable, and dysphagia score (DS) of >
Conditions
Interventions
None listed
Sponsors
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Residual cancerous stenosis after CRT/RT, unable to be radically resected, DS of 2 or more, and difficulty in eating an adequate diet orally, esophageal squamous cell carcinoma to be considered for stenting. Basically, stenting is performed in most cases where the normal diameter does not pass through, but it does not matter whether the normal diameter scope passes through or not. 2) Stenting is performed, or a percutaneous endoscopic gastrostomy or CV port is created or continued. 3) Age 18 years or older at the time of consent. 4) ECOG Performance Status (PS) of 0, 1, or 2. 5) Patients have been fully informed about their participation in the study and their written consent has been obtained.
Exclusion criteria
Exclusion criteria: 1) Patients on peripheral infusion without stenting, percutaneous endoscopic gastrostomy, or CV port 2) Patients with a total radiotherapy dose of less than 30 Gy 3) Patients whose pathology is other than squamous cell carcinoma such as adenocarcinoma 4) Patients with fistulas such as esophagobronchial or esophagopulmonary fistulas 5) Patients with stents other than low radial force stents (Niti-S esophageal stent, Evolution esophageal stent) 6) Patients whose esophageal stricture is close to the pharynx or who have coagulation abnormalities that preclude stenting 7) Patients with infections requiring systemic treatment 8) Pregnant or possibly pregnant or breastfeeding women 9) Patients with psychosis, psychiatric symptoms, or dementia that would make it difficult for them to participate in the study 10) Other patients who are considered by the investigator to be inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of serious adverse events due to stenting | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of non-worsening of the utility index 1 week after stenting Rate of improvement in EORTC QLQ-OES18 after 1 week of stenting Duration of oral intake and rate of duration of oral intake with stenting Change in Dysphagia Score and rate of improvement with stenting Rate of success of stenting procedure Rate of serious adverse events due to percutaneous endoscopic gastrostomy /CV port placement Rate of improvement in EORTC QLQ-OES18 at 1 and 3 months after stenting and percutaneous endoscopic gastrostomy /CV port placement Overall survival by each treatment EQ-5D-5L change by each treatment Rate of serious adverse events by pretreatment (by radiation dose) and posttreatment history Rate of Adverse Events by each treatment Change in Alb, PNI (prognostic nutritional index) after 1 month of treatment by each treatment Weight change by each treatment | — |
Countries
Japan
Contacts
Public ContactNobuhito Ito
Aichi Cancer Center Hospital Department of Endoscopy
Outcome results
None listed