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ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors

NCT01768104 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-01-15

No results posted yet for this study

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.

Conditions

  • Upper Gastrointestinal Submucosal Tumors (SMTs)
  • Gastrointestinal Stromal Tumors (GISTs)
  • Leiomyoma

Interventions

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)

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)

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Wei Gong, M.D. · Department of Gastroenterology, Nanfang Hospital of Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01768104 on ClinicalTrials.gov