ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors

Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01768104
• Other study ID #: NFEK-201211-K1
• Secondary ID: 201120
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2013
• Last updated: January 11, 2013
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2011
• Source: Nanfang Hospital of Southern Medical University
• Contact: Wei Gong, M.D.
• Phone: +86 15820290385
• Email: gwei203[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• ESTD
A 2-cm longitudinal mucosal incision was made, approximately 5cm proximal to the submucosal tumor (SMTs). Submucosal dissection was done, creating a submucosal tunnel until the tumor was visible. Dissection was done along the margin of the tumor. After the tumor had been removed, the potential bleeding area in the tunnel was coagulated. 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)
• VATS
General anesthesia with double lumen intubation. Three to four cameras or working ports are placed over the chest wall. After the lesion is visualized by thoracoscopy, the mediastinal pleura over the tumor is incised longitudinally by an endoscopic hook electrocauterizer. The mass is exposed after the overlying muscle is split longitudinally. 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. 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)

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Zhao 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	En bloc resection	The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation	During the operation	No
Secondary	Curative resection	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	No
Secondary	Procedure related complication	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	Yes
Secondary	Short-term morbidity	Any cause death	From date of randomization until the date of death from any cause, assessed up to 3 months	Yes
Secondary	Local recurrence	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	Yes
Secondary	Quality of life	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	Yes

External Links

•   Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical University
•   Homepage of Nanfang Hospital of Southern Medical University