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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03037034
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
In-Kyung Yoo, 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.

Condition or disease Intervention/treatment Phase
Gastric Subepithelial Tumor Device: Forcep Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria: a Promising Forcep Strip Method
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Forcep Strip Method Treatment
patients who have Gastrointestinal Subepithelial Tumors Originating from the Muscularis Propria are enrolled
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.




Primary Outcome Measures :
  1. Complete resection rate [ Time Frame: 1 week ]
    Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method


Secondary Outcome Measures :
  1. The mean procedure time [ Time Frame: 1day ]
    procedure time of submucosal tumor removal using forcep strip method

  2. mean tumor size [ Time Frame: 1day ]
    tumor size of submucosal tumor removed by forcep strip method

  3. the mean hospitalization time [ Time Frame: 1week ]
    patient hospitalization time during submucosal tumor removal

  4. Adverse Events [ Time Frame: 5 days ]
    Peri-interventional adverse events whether related or not

  5. Tumor status after endoscopic resection [ Time Frame: 10 months ]
    Local result during follow up after Forcep Strip Method



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037034


Locations
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Korea, Republic of
Korea University Anam Hospital
Seoul, Anamdong , Seongbuk-gu, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Investigators
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Principal Investigator: Hoon Jai Chun Korea University Anam Hospital

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Responsible Party: In-Kyung Yoo, Clinical Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT03037034     History of Changes
Other Study ID Numbers: Novel Forcep Srip Method
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No