refractory benign esophageal strictures after curative treatment of esophageal cancer
Conditions
Interventions
BD stent
Sponsors
National Cancer Center Hospital East
Piolax Medical Devices,Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Esophageal cancer is considered as cured without relapse by radical resection, endoscopic therapy, radiotherapy, or chemoradiotherapy. 2)Benign esophageal stricture which meets all following criteria. i)Dysphagia score of >= 2 ii)Endoscope (diameter of 9-11 mm) could not pass the stricture. iii) Non-malignant finding with endoscopic examination. iv) Non-malignant finding is proven with biopsy at the stricture. 3)Refractory esophageal stricture which meets one or both of the following criteria. i)Number of balloon dilatations or bougies >= 5 and / or ii)Number of Radial Incision and Cutting (RIC) >= 1 4)Stent insertion could conduct safely (i.e. meets any criterion as follows) i)No esophageal fistula ii)Distance from esophageal orifice to stricture is >= 3cm iii)Length of stricture is <= 8cm 5)>= 20 years old. 6)ECOG performance status of <= 2. 7)Adequate organ function. 8)Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Delivery system (28F) could not pass the stricture even if any endoscopic dilation was conducted before BD stent insertion. 2)Systemic treatment is indicated for bacterial or fungal infection. 3)Synchronous other cancer except carcinoma in situ, intramucosal carcinoma or watchful waiting prostate cancer. 4)Radiation therapy within 6 months prior to enrollment. 5)Lugol-voiding lesion near the strictures or multiple Lugol-voiding lesion throughout the esophagus. 6)In opioid analgesics therapy. 7)Impossible to discontinue antithrombotic drug. 8)Severe dysphagia. 9)Women during pregnancy or breast-feeding. 10)In chronic treatment with steroids. 11)Patient is judged to be inappropriate for enrollment of the study for any reason by the investigator. 12)Prior treatment using BD stent placement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of dysphagia score improvement at 3-month | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of dysphagia score improvement at 6-month Proportion of stricture improvement at 3-month Proportion of stricture improvement at 6-month Dysphagia free survival Technical success rate of stent insertion Stent migration rate Adverse events | — |
Countries
Japan
Contacts
Public ContactTomonori Yano
National Cancer Center Hospital East Gastrointestinal Oncology Division
Outcome results
None listed