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

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

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)

ESTD

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)

VATS

Wei Gong, M.D.

Xiaobing Cui, M.D.

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.

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 .

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

The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation

The curative resection was defined as the resected specimen with vertical and lateral margins free of neoplasia in pathological diagnosis.

Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak, etc.

Local recurrence was defined as endoscopic or histological diagnosis of cancer at the resected site in follow-up

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

Nanfang Hospital, Southern Medical University

Esophageal Diseases

Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.

Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.

Key Hole Biopsy ( KHB)

Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine mitotic activity is evaluated. In case of failure of this method, the second one is performed.

EUS-FNA

Vincent Zoundjiekpon, MD

Upper Gastrointestinal Submucosal Tumors are tumors arising from subepithelial layers of esophageal, gastric or duodenal wall. They usually have an intact mucosa lining on the inner surface. The prognosis and treatment of these tumors depend on their correct diagnostics and mitotic activity in case of Gastrointestinal Stromal Tumors (GIST). A standard forceps biopsy of mucosa is usually not helpful. Therefore, biopsy techniques capable of reaching deeper layer of Upper GUT are needed. The investigators compare KHB and EUS-FNA in the diagnostics of Upper gastrointestinal Submucosal Tumors.

Patients with endoscopically detected submucosal tumors of Upper GUT with diameter ≥ 2cm are enrolled in the trial.

According to randomization, the patients are allocated to either EUS-FNA by 22G needle or KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with subsequent histological/cytological and immunohistochemical evaluation of the specimen. The success of tissue diagnostics was evaluated as well as the possibility to determine the mitotic activity in case of GIST. In case of failure of the initial method, the other method was performed (cross-over design). Patients are hospitalized and kept under observation during 24 hours after the biopsy.

EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors

Endosonography-Guided Fine-Needle-Aspiration (EUS-FNA) Versus Key Hole Biopsy (KHB) in Diagnostics of Upper Gastrointestinal Submucosal Tumors - a Randomized Trial

Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are randomized and then are allocated to either EUS-FNA by 22G needle or KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with subsequent histological/cytological and imunohistochemical evaluation of the specimen. The success of tissue diagnostics was evaluated.In case of failure of the initial method, the other method was performed (cross-over design).

Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are randomized and then allocated to either EUS-FNA by 22G needle or KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with subsequent histological/cytological and imunohistochemical evaluation of the specimen. In case of GIST the possibility to determine the mitotic activity was evalueted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors	NCT01768104	Upper Gastroint... Gastrointestina... Leiomyoma	ESTD VATS	15 Years - 75 Years	Nanfang Hospital, Southern Medical University
EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors	NCT02025244	Other Specified...	Key Hole Biopsy... EUS-FNA	18 Years - 95 Years	Vitkovice Hospital
EUS-FNA Versus KHB in Diagnostics of Upper Gastrointestinal Submucosal Tumors	NCT02025244	Other Specified...	Key Hole Biopsy... EUS-FNA	18 Years - 95 Years	Vitkovice Hospital
ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors	NCT01768104	Upper Gastroint... Gastrointestina... Leiomyoma	ESTD VATS	15 Years - 75 Years	Nanfang Hospital, Southern Medical University
ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors	NCT01768104	Upper Gastroint... Gastrointestina... Leiomyoma	ESTD VATS	15 Years - 75 Years	Nanfang Hospital, Southern Medical University

Spots Global Cancer Trial Database for upper gastrointestinal submucosal tumors