Clinical trial NCT01768104: ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors
Official title: Endoscopic Submucosal Tunnel Dissection Versus Video-assisted Thoracoscopic Surgery for Upper Gastrointestinal Submucosal Tumors: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Gastrointestinal Submucosal Tumors (SMTs)
Gastrointestinal Stromal Tumors (GISTs)
Leiomyoma
Keywords: 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
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: En bloc resection
timeFrame: During the operation
Secondary outcomes:
measure: Curative resection
timeFrame: From date of randomization until the date of pathological diagnosis, an expected average of 7 days
measure: Procedure related complication
timeFrame: 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
measure: Short-term morbidity
timeFrame: From date of randomization until the date of death from any cause, assessed up to 3 months
measure: Local recurrence
timeFrame: From date of randomization until the follow-up ended, assessed up to 2 years
measure: Quality of life
timeFrame: From date of randomization until the follow-up ended, assessed up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Gastroenterology, Nanfang Hospital of Southern Medical University
name: Wei Gong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.