Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria

Not Applicable

Completed

• Conditions: Gastric Subepithelial Tumor
• Interventions: Device: Forcep

• Registration Number: NCT03037034
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive patients who had clinical indications for lesion removal. Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current. In brief, the tumor was dissected from the muscularis propria layer and then carefully removed using forceps. Demographic data, indication for intervention, safety of the procedure and follow-up will be assessed.

Detailed Description

After the target lesion was identified, several marking dots were made around the lesion, using the hot biopsy forcep. A 0.9% saline solution mixed with epinephrine (1:10,000) and indigo carmine dye was injected along the border of the tumor to raise the gastric mucosa. Then, a circumferential incision was made along the margin of the targeted lesion, using the hot biopsy forceps, and the superficial mucosa was removed. Repeated injection was performed into the submucosal layer. The surrounding tissue was then carefully dissected using the hot biopsy forceps to the level of the deepest submucosal layer. The adjacent tissue was grasped using the forceps and pulled away, forming a "tent". To ensure complete resection, the muscular fibers and stalks that connected the tumor to the propria layer were shelled along the capsule of the tumor, using the coagulating forceps. The investigators used a coagulating forceps when strip the tissue of the outer longitudinal layer. Visible blood vessels in the submucosal layer were directly coagulated using coagulating forceps. After the lesion was removed, further visible blood vessels were coagulated. The hot biopsy forcep was used to apply a forced coagulation current (80 W, Effect 2, VIO300D; Erbe, Germany). However, coagulating forceps with a soft coagulation current (60 W, Effect 6, VIO300D; Erbe, Germany) were used to cut muscle fibers adjacent to the tumor or hemostasis.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Status Verified: 2017-01
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-30
• Last Update Submitted: 2017-01-30
• Study First Posted: 2017-01-31
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. the tumor size had increased on the follow up gastroscopy,
2. the EUS showed a well demarcated GI SET, or
3. they requested an endoscopic excision because the tumor was causing them anxiety.

Exclusion Criteria

1. they had predominantly extraluminal growth,
2. they were ill demarcated, or
3. the EUS showed adjacent lymph nodes with a malignant appearance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Forcep Strip Method Treatment	Forcep	patients who have Gastrointestinal Subepithelial Tumors Originating from the Muscularis Propria are enrolled

Primary Outcome Measures

Name	Time	Method
Complete resection rate	1 week	Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method

Secondary Outcome Measures

Name	Time	Method
The mean procedure time	1day	procedure time of submucosal tumor removal using forcep strip method
Adverse Events	5 days	Peri-interventional adverse events whether related or not
mean tumor size	1day	tumor size of submucosal tumor removed by forcep strip method
the mean hospitalization time	1week	patient hospitalization time during submucosal tumor removal
Tumor status after endoscopic resection	10 months	Local result during follow up after Forcep Strip Method

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Anamdong , Seongbuk-gu, Korea, Republic of