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Completed

NCT Number: NCT03037034

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, Anamdong , Seongbuk-gu, 136-705, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Forcep

Device

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 outcomes

  1. Complete resection rate

    Time frame: 1 week

    Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 31, 2017
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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