ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors
Endoscopic Submucosal Tunnel Dissection Versus Video-assisted Thoracoscopic Surgery for Upper Gastrointestinal Submucosal Tumors: a Prospective Randomized Controlled Trial
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 5, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 15, 2013
December 1, 2011
2 years
January 5, 2013
January 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
En bloc resection
The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation
During the operation
Secondary Outcomes (5)
Curative resection
From date of randomization until the date of pathological diagnosis, an expected average of 7 days
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
Short-term morbidity
From date of randomization until the date of death from any cause, assessed up to 3 months
Local recurrence
From date of randomization until the follow-up ended, assessed up to 2 years
Quality of life
From date of randomization until the follow-up ended, assessed up to 2 years
Study Arms (2)
ESTD
EXPERIMENTALEndoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs)
VATS
ACTIVE COMPARATORVideo-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs)
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- Between 18 and 75 years of age
- Patient with upper gastrointestinal submucosal tumor
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (2)
Gong W, Xiong Y, Zhi F, Liu S, Wang A, Jiang B. Preliminary experience of endoscopic submucosal tunnel dissection for upper gastrointestinal submucosal tumors. Endoscopy. 2012 Mar;44(3):231-5. doi: 10.1055/s-0031-1291720. Epub 2012 Feb 21.
PMID: 22354823BACKGROUNDZhao Y, Cai K, Liu D, Wu H, Xiong G, Wang H, Huang Z, Cai R, Wu X. [Video-assisted thoracoscopic removal of esophageal leiomyomas with intraoperative tumor location by endoscopy]. Nan Fang Yi Ke Da Xue Xue Bao. 2012 Apr;32(4):586-8. Chinese.
PMID: 22543150BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Gong, M.D.
Department of Gastroenterology, Nanfang Hospital of Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2013
First Posted
January 15, 2013
Study Start
December 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 15, 2013
Record last verified: 2011-12