Neoplasms

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Leiomyoma

Gastrointestinal Stromal Tumors

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Neoplasms, Connective Tissue

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Gastrointestinal Neoplasms

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Anesthetics

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

Musculoskeletal Diseases

Nervous System Diseases

Symptoms and General Pathology

Muscle Cramp

Spasm

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Antineoplastic Agents

Other Dietary Supplements

Imatinib Mesylate

Carnitine

L-carnitine 500mg three times daily (per oral)

Placebo 500mg three times daily (per oral)

* L-carnitine VS Placebo is randomized (1:1)
* L-carnitine 500mg TID(PO),
* First evaluation will be performed at 8 weeks and then unblinding will be done. If symptoms continue after treatment, dose escalation in L-carnitine group by 1000mg TID (PO). If symptoms continue after treatment in Placebo group, L-carnitine 500mg TID(PO) will be given.

L-carnitine

Placebo

Yoon-Koo Kang, MD, PhD

we aim to evaluate the efficacy of L-carnitine for the treatment of muscle cramps after imatinib in patients with GIST and apply in the future.

One of the most common side effects of imatinib treatment, muscle cramps occur in about 30% of patients with gastrointestinal stromal tumor (GIST) receiving treatment with imatinib.

It affects the quality of life (QoL) of patients and could also be a factor that affects compliance with treatment. Some studies suggest that L-carnitine may improve muscle cramps associated with cirrhosis or hemodialysis. However, the efficacy of L-carnitine for muscle cramps occurring after imatinib treatment has yet to be reported. Thus, we aim to evaluate the efficacy of L-carnitine for the treatment of muscle cramps after imatinib in patients with GIST and apply in the future.

L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors

Phase III Study of L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Patients With Gastrointestinal Stromal Tumors (GISTs) (Single-center Study)

Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score \> 4) decreased by less than 50% in 4 weeks excluding the first 4 weeks of drug administration

\*numeric rating scale scores(range, 0-10) -\> higher score is worse outcome

Change in average numeric rating scale scores(range, 0-10) of muscle cramps in 4 weeks excluding the first 4 weeks of drug administration

\*numeric rating scale scores(range, 0-10) -\> higher score is worse outcome

Rate of patients who have duration of muscle cramps (numeric rating scale score \> 4)

that was decreased by more than 50% in next 4 weeks excluding the first 4 weeks of drug administration

\*numeric rating scale scores(range, 0-10) -\> higher score is worse outcome

Evaluation of the change in the Quality of Life in 4 weeks

Recurrence is defined as 1) frequency of muscle cramps (NRS \> 4) becomes more than 50% of baseline and 2) frequency of muscle cramps (NRS \> 4) get twice worse than most improved time (when evaluated every 4 weeks)

Hanmi Pharmaceutical Company Limited

Asan Medical Center

Professor

Sunitinib

regorafenib 100 mg po od daily, every 4 weeks (28 day)

Regorafenib

Randomized, placebo-controlled, phase III study of regorafenib 160 mg once daily on intermittent dosing schedule of 3 weeks on treatment followed by 1 weeks off demonstrated the significant benefit of regorafenib in terms of PFS in patients with GISTs who had failed to both imatinib and sunitinib. However, there are concerns that tumors and tumor-related symptoms may be progressed during off treatment period. Investigators hypothesize that continuous dosing schedule of regorafenib might be feasible and effective to prevent disease flare on off-treatment period. Based on the results of previous dose escalation study for continuous regorafenib dosing, we investigate the 100 mg daily dose of regorafenib in patients with TKI-refractory GISTs.

Phase II Study of Regorafenib Continuous Dosing of Regorafenib in Patients With GISTs

Phase II Study of Continuous Dosing of Regorafenib in Patients With Gastrointestinal Stromal Tumors (GISTs) After Failure of Imatinib and Sunitinib: GIST Regorafenib Continuous Dosing

Disease control rate (CR + PR + SD) lasting for at least 12 weeks according to the RECIST v1.1

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
L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors	NCT03426722	Gastrointestina...	L-carnitine Placebo	18 Years -	Asan Medical Center
L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors	NCT03426722	Gastrointestina...	L-carnitine Placebo	18 Years -	Asan Medical Center
Phase II Study of Regorafenib Continuous Dosing of Regorafenib in Patients With GISTs	NCT02889328	Gastrointestina...	Regorafenib	20 Years -	Asan Medical Center
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
L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors	NCT03426722	Gastrointestina...	L-carnitine Placebo	18 Years -	Asan Medical Center

Spots Global Cancer Trial Database for gastrointestinal stromal tumors (gists)