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

Gastric Subepithelial Tumor Clinical Trial

Official title:

Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria: a Promising Forcep Strip Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037034
• Other study ID #: Novel Forcep Srip Method
• Status: Completed
• Phase: N/A
• First received: January 25, 2017
• Last updated: January 30, 2017
• Start date: January 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: January 2017
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Subepithelial Tumor

Intervention

Device:
• Forcep
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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul	Anamdong , Seongbuk-gu

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete resection rate	Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method	1 week
Secondary	The mean procedure time	procedure time of submucosal tumor removal using forcep strip method	1day
Secondary	mean tumor size	tumor size of submucosal tumor removed by forcep strip method	1day
Secondary	the mean hospitalization time	patient hospitalization time during submucosal tumor removal	1week
Secondary	Adverse Events	Peri-interventional adverse events whether related or not	5 days
Secondary	Tumor status after endoscopic resection	Local result during follow up after Forcep Strip Method	10 months