ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors

NCT ID: NCT01768104

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-12-31

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 .

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESTD

Endoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs)

Group Type: EXPERIMENTAL

ESTD

Intervention Type: PROCEDURE

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)

VATS

Video-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs)

Group Type: ACTIVE_COMPARATOR

VATS

Intervention Type: PROCEDURE

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: PROCEDURE

Other Intervention Names

Endoscopic submucosal tunnel dissection (ESTD); Submucosal tunneling endoscopic resection (STER); Submucosal endoscopic tumor resection (SET); Video-assisted thoracoscopic surgery; Video-thoracoscopic enucleation

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Gong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Nanfang Hospital of Southern Medical University

Locations

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Gong, M.D.

Role: CONTACT

gwei203@yahoo.com.cn

+86 15820290385

Facility Contacts

Xiaobing Cui, M.D.

Role: primary

xbing119@gmail.com

+86 13631312723

References

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.

Reference Type: BACKGROUND

PMID: 22354823 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22543150 (View on PubMed)

Related Links

http://www.nfyy.com/

Homepage of Nanfang Hospital of Southern Medical University

http://www.xhbnet.com/

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

Other Identifiers

201120

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NFEK-201211-K1

Identifier Type: -

Identifier Source: org_study_id