ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Upper Gastrointestinal Submucosal Tumors (SMTs); Leiomyoma; Gastrointestinal Stromal Tumors (GISTs)

Treatments: Procedure: VATS; Procedure: ESTD

Study type: Interventional

Funder types: Other

Identifiers

NCT01768104

201120 (Other Grant/Funding Number)

NFEK-201211-K1

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 200 estimated patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ESTD

Experimental group

Description:

Endoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs)

Treatment:

Procedure: ESTD

VATS

Active Comparator group

Description:

Video-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs)

Treatment:

Procedure: VATS