ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Nanfang Hospital of Southern Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01768104
First received: January 5, 2013
Last updated: January 11, 2013
Last verified: December 2011
  Purpose

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.


Condition Intervention
Upper Gastrointestinal Submucosal Tumors (SMTs)
Gastrointestinal Stromal Tumors (GISTs)
Leiomyoma
Procedure: ESTD
Procedure: VATS

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
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)
Arms Assigned Interventions
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

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 .

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768104

Contacts
Contact: Wei Gong, M.D. +86 15820290385 gwei203@yahoo.com.cn

Locations
China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Xiaobing Cui, M.D.    +86 13631312723    xbing119@gmail.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Principal Investigator: Wei Gong, M.D. Department of Gastroenterology, Nanfang Hospital of Southern Medical University
  More Information

Additional Information:
Publications:
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01768104     History of Changes
Other Study ID Numbers: NFEK-201211-K1, 201120
Study First Received: January 5, 2013
Last Updated: January 11, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:
upper gastrointestinal submucosal tumors
SMTs
Gastrointestinal stromal tumors
GISTs
Leiomyoma
Endoscopic submucosal tunnel dissection
ESTD
Submucosal tunneling endoscopic resection
STER
Submucosal endoscopic tumor resection
SET

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Gastrointestinal Stromal Tumors
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014