ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors

January 11, 2013 updated by: Nanfang Hospital of Southern Medical University

Endoscopic Submucosal Tunnel Dissection Versus Video-assisted Thoracoscopic Surgery for Upper Gastrointestinal Submucosal Tumors: a Prospective Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESTD
Endoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs)
Procedure: ESTD
  1. A 2-cm longitudinal mucosal incision was made, approximately 5cm proximal to the submucosal tumor (SMTs).
  2. Submucosal dissection was done, creating a submucosal tunnel until the tumor was visible.
  3. Dissection was done along the margin of the tumor.
  4. After the tumor had been removed, the potential bleeding area in the tunnel was coagulated.
  5. Endoclips were used to close the entry of the submucosal tunnel.

(Gong W et al. ESTD for upper gastrointestinal submucosal tumors… Endoscopy 2012; 44: 231-235)

Other Names:
  • Endoscopic submucosal tunnel dissection (ESTD)
  • Submucosal tunneling endoscopic resection (STER)
  • Submucosal endoscopic tumor resection (SET)
Active Comparator: VATS
Video-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs)
Procedure: VATS
  1. General anesthesia with double lumen intubation.
  2. Three to four cameras or working ports are placed over the chest wall.
  3. After the lesion is visualized by thoracoscopy, the mediastinal pleura over the tumor is incised longitudinally by an endoscopic hook electrocauterizer.
  4. The mass is exposed after the overlying muscle is split longitudinally.
  5. The retracting suture is placed over the mass and then meticulously dissect the plane between the mass and the submucosal layer. The integrity of the mucosa must be checked.
  6. The muscle layer is re-approximated and a chest tube is place through one of the ports.

(Luh et al. World Journal of Surgical Oncology 2012, 10:52)

Other Names:
  • Video-assisted thoracoscopic surgery
  • Video-thoracoscopic enucleation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
En bloc resection
Time Frame: During the operation
The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation
During the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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
From date of randomization until the follow-up ended, assessed up to 2 years
Curative resection
Time Frame: 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.
From date of randomization until the date of pathological diagnosis, an expected average of 7 days
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
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
Time Frame: From date of randomization until the date of death from any cause, assessed up to 3 months
Any cause death
From date of randomization until the date of death from any cause, assessed up to 3 months
Local recurrence
Time Frame: 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
From date of randomization until the follow-up ended, assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Wei Gong, M.D., Department of Gastroenterology, Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

January 5, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEK-201211-K1
  • 201120 (New business and New Technology Project of Nanfang Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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