ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors

Not Applicable

• Conditions: Gastrointestinal Stromal Tumors (GISTs); Leiomyoma; Upper Gastrointestinal Submucosal Tumors (SMTs)
• Interventions: Procedure: ESTD; Procedure: VATS

• Registration Number: NCT01768104
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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 .

Study Timeline

• Status Verified: 2011-12
• Study Start: 2011-12
• Study First Submitted: 2013-01-05
• Study First Submitted QC: 2013-01-11
• Last Update Submitted: 2013-01-11
• Study First Posted: 2013-01-15
• Last Update Posted: 2013-01-15
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESTD	ESTD	Endoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs)
VATS	VATS	Video-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs)

Primary Outcome Measures

Name	Time	Method
En bloc resection	During the operation	The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation

Secondary Outcome Measures

Name	Time	Method
Curative resection	From date of randomization until the date of pathological diagnosis, an expected average of 7 days	The curative resection was defined as the resected specimen with vertical and lateral margins free of neoplasia in pathological diagnosis.
Procedure related complication	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	Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak, etc.
Short-term morbidity	From date of randomization until the date of death from any cause, assessed up to 3 months	Any cause death
Local recurrence	From date of randomization until the follow-up ended, assessed up to 2 years	Local recurrence was defined as endoscopic or histological diagnosis of cancer at the resected site in follow-up
Quality of life	From date of randomization until the follow-up ended, assessed up to 2 years	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

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China