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| ID | Type | Description | Link |
|---|---|---|---|
| 201120 | Other Grant/Funding Number | New business and New Technology Project of Nanfang Hospital |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESTD | Experimental | Endoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs) |
|
| VATS | Active Comparator | Video-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESTD | Procedure |
(Gong W et al. ESTD for upper gastrointestinal submucosal tumors… Endoscopy 2012; 44: 231-235) |
| Measure | Description | Time Frame |
|---|---|---|
| En bloc resection | The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation | During the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Curative resection | The curative resection was defined as the resected specimen with vertical and lateral margins free of neoplasia in pathological diagnosis. | From date of randomization until the date of pathological diagnosis, an expected average of 7 days |
| Procedure related complication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Gong, M.D. | Contact | +86 15820290385 | gwei203@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei Gong, M.D. | Department of Gastroenterology, Nanfang Hospital of Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22354823 | Background | Gong W, Xiong Y, Zhi F, Liu S, Wang A, Jiang B. Preliminary experience of endoscopic submucosal tunnel dissection for upper gastrointestinal submucosal tumors. Endoscopy. 2012 Mar;44(3):231-5. doi: 10.1055/s-0031-1291720. Epub 2012 Feb 21. | |
| 22543150 | Background | Zhao Y, Cai K, Liu D, Wu H, Xiong G, Wang H, Huang Z, Cai R, Wu X. [Video-assisted thoracoscopic removal of esophageal leiomyomas with intraoperative tumor location by endoscopy]. Nan Fang Yi Ke Da Xue Xue Bao. 2012 Apr;32(4):586-8. Chinese. |
| Label | URL |
|---|---|
| Homepage of Nanfang Hospital of Southern Medical University | View source |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
| VATS | Procedure |
(Luh et al. World Journal of Surgical Oncology 2012, 10:52) |
|
|
Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak, etc. |
| 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 |
| Short-term morbidity | Any cause death | From date of randomization until the date of death from any cause, assessed up to 3 months |
| Local recurrence | Local recurrence was defined as endoscopic or histological diagnosis of cancer at the resected site in follow-up | From date of randomization until the follow-up ended, assessed up to 2 years |
| Quality of life | 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 | From date of randomization until the follow-up ended, assessed up to 2 years |
| Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical University | View source |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D013906 | Thoracoscopy |
| D020535 | Video-Assisted Surgery |
| D019616 | Thoracic Surgical Procedures |