ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors
Conditions
Upper Gastrointestinal Submucosal Tumors (SMTs) - Gastrointestinal Stromal Tumors (GISTs) - Leiomyoma
Conditions: official terms
Gastrointestinal Stromal Tumors - Leiomyoma - Neoplasms
Conditions: Keywords
upper gastrointestinal submucosal tumors, SMTs, Gastrointestinal stromal tumors, GISTs, Leiomyoma, Endoscopic submucosal tunnel dissection, ESTD, Submucosal tunneling endoscopic resection, STER, Submucosal endoscopic tumor resection, SET
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ESTD Type: Procedure
Name: VATS Type: Procedure
Overall Status
Recruiting
Summary
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.
Detailed Description
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 .
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 15 Years
Gender: Both
Criteria: Inclusion Criteria:

- Between 18 and 75 years of age

- Patient with upper gastrointestinal submucosal tumor

- Signed informed consent

Exclusion Criteria:

- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk

- Endoscopic ultrasound (EUS) or CT signs of metastasis

- Mega-oesophagus (greater than 7 cm) or Oesophageal diverticula in the distal oesophagus

- Previous oesophageal or gastric surgery

- Pregnancy or lactation women, or ready to pregnant women

- Not capable of filling out questionnaires
Location
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Xiaobing Cui, M.D. - +86 13631312723 - xbing119@gmail.com
Start Date
December 2011
Completion Date
December 2013
Sponsors
Nanfang Hospital of Southern Medical University
Source
Nanfang Hospital of Southern Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page