Clinical trial NCT03037034: Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria
Official title: Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria: a Promising Forcep Strip Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Subepithelial Tumor
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete resection rate
timeFrame: 1 week
Secondary outcomes:
measure: The mean procedure time
timeFrame: 1day
measure: mean tumor size
timeFrame: 1day
measure: the mean hospitalization time
timeFrame: 1week
measure: Adverse Events
timeFrame: 5 days
measure: Tumor status after endoscopic resection
timeFrame: 10 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Anamdong , Seongbuk-gu
Study officials:
affiliation: Korea University Anam Hospital
name: Hoon Jai Chun
role: PRINCIPAL_INVESTIGATOR
References: