To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.
This multicenter, prospective, randomized, controlled study aims to evaluate the efficacy and safety of the tunnel technique in ESD of superficial esophageal squamous cell carcinoma (ESCC). Specifically the tunnel technique would be compared to conventional method on the procedure time and the muscular layer injury rate in patients scheduled for ESD with indication of ESCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
During the ESTD procedure,after marking and submucosal injection, incisions were made at both the anal and oral sides of the lesion, and the submucosa under the lesion was then dissected to create a tunnel between the distal and proximal incisions. When the endscope reached the lower incision, the distal end of the esophageal lumen could be visualized , then two lateral mucosal incisions were made, thus completing the ESD procedure.
The ESD procedure involved marking,injection,circumferential cutting, submucosal dissection.
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
The procedure time
Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.
Time frame: day 1
The rate of bleeding during operation
The hemorrhage observed during the operation
Time frame: day 1
The rate of injury to the muscular layer
The injury to the muscular layer observed during the operation
Time frame: day 1
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