Leiomyoma Clinical Trial
Official title:
Endoscopic Submucosal Tunnel Dissection Versus Video-assisted Thoracoscopic Surgery for Upper Gastrointestinal Submucosal Tumors: a Prospective Randomized Controlled Trial
The purpose of this study is to determine the efficacy and safety of endoscopic submucosal tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the treatment of upper gastrointestinal submucosal tumors.
Most upper gastrointestinal submucosal tumors (SMTs), especially the gastrointestinal
stromal tumors (GISTs) and leiomyoma, are regarded as benign if they are less than 3cm in
size. Thus, it has been suggested that patients should receive periodic endoscopic follow-up
in case of gradual changes in size; however this can be stressful and troublesome for
patients. Nevertheless, some of these tumors do have a malignant potential, and management
by periodic endoscopic surveillance may lead to delayed diagnosis of malignancy. Therefore,
it is necessary to remove the SMTs.
To date, several approaches have been used for the treatment of upper gastrointestinal SMTs,
including open, thoracoscopic and laparoscopic surgery, and endoscopic approaches such as
band ligation, endoscopic submucosal dissection (ESD), and endoscopic full-thickness
resection (EFR). However, the surgical approaches are invasive with a longer hospital stay
and greater cost, while the endoscopic approaches were limited by technical difficulty,
incomplete resections and risk of perforation.
Recently, the technique of peroral endoscopic myotomy (POEM) for esophageal achalasia was
introduced, a procedure in which a submucosal tunnel is created to expose and dissect the
circular muscle of the esophagus. Inspired by the POEM approach, we have successfully used a
similar method, endoscopic submucosal tunnel dissection (ESTD), to resect SMTs in upper
gastrointestinal.
However, the long-term efficacy and safety of ESTD were not determined, and there was no
prospective study compared the ESTD with other conventional approaches. Therefore, we plan
to conduct this prospective randomized controlled trial, aim to determine the efficacy and
safety of ESTD, compared with the pneumatic dilation, in the treatment of upper
gastrointestinal SMTs originating from the muscularis propria layer .
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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