ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors
Recruitment status was Recruiting
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.
Upper Gastrointestinal Submucosal Tumors (SMTs)
Gastrointestinal Stromal Tumors (GISTs)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endoscopic Submucosal Tunnel Dissection Versus Video-assisted Thoracoscopic Surgery for Upper Gastrointestinal Submucosal Tumors: a Prospective Randomized Controlled Trial|
- En bloc resection [ Time Frame: During the operation ] [ Designated as safety issue: No ]The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation
- Curative resection [ Time Frame: From date of randomization until the date of pathological diagnosis, an expected average of 7 days ] [ Designated as safety issue: No ]The curative resection was defined as the resected specimen with vertical and lateral margins free of neoplasia in pathological diagnosis.
- Procedure related complication [ Time Frame: From date of operation until the occurrence of the procedure related complication, which most occur within 7 days after operation, assessed up to 2 years ] [ Designated as safety issue: Yes ]Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak, etc.
- Short-term morbidity [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 3 months ] [ Designated as safety issue: Yes ]Any cause death
- Local recurrence [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: Yes ]Local recurrence was defined as endoscopic or histological diagnosis of cancer at the resected site in follow-up
- Quality of life [ Time Frame: From date of randomization until the follow-up ended, assessed up to 2 years ] [ Designated as safety issue: Yes ]Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Endoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs)
(Gong W et al. ESTD for upper gastrointestinal submucosal tumors… Endoscopy 2012; 44: 231-235)
Active Comparator: VATS
Video-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs)
(Luh et al. World Journal of Surgical Oncology 2012, 10:52)
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 .
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768104
|Contact: Wei Gong, M.D.||+86 firstname.lastname@example.org|
|Nanfang Hospital of Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Xiaobing Cui, M.D. +86 13631312723 email@example.com|
|Principal Investigator:||Wei Gong, M.D.||Department of Gastroenterology, Nanfang Hospital of Southern Medical University|