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OpenTrials
Completed

NCT Number: NCT03136354

Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer

The investigators compared the perioperative, oncological, functional and immunological outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for treatment of early gastric cancer. With virtually no abdominal incisions and minimal pain induced, endoscopic submucosal dissection is expected to be less invasive when compared to laparoscopic assisted gastrectomy for treatment of early gastric cancer. This study will show that endoscopic submucosal dissection is associated with a significantly better perioperative recovery and less immunological disturbance. Moreover, it will also induce a better long term outcomes as the stomach can be preserved, hence the digestive function is maintained to prevent long term functional morbidities of the gastrointestinal tract.

This study will be the unique first study in the literature to show that intramucosal early gastric cancer can be adequately treated by endoscopic submucosal dissection with better perioperative, functional and quality of life outcomes when compared to laparoscopic assisted gastrectomy.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, 00000

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma (intestinal type)
  • Preoperative investigation with magnifying endoscopy and / or EUS predicted to be mucosal lesion
  • Any tumor size if the early gastric cancer has no ulceration
  • Tumor size ≤ 3cm if the early gastric cancer has ulceration

Exclusion criteria

  • Gastric cancer with preoperative magnifying endoscopy and / or EUS predicted to beyond submucosal invasion
  • Poorly differentiated or signet ring cell adenocarcinoma
  • Age > 80 or < 16
  • Pregnancy
  • ASA > IV

Treatment and study plan

Endoscopic submucosal dissection

Procedure

Laparoscopic assisted Gastrectomy

Procedure

Primary outcomes

  1. Complication

    Time frame: 30 days after procedure

Secondary outcomes

  1. Postop VAS score on pain measurement

    Time frame: 30 days

    Measured by VAS pain score daily until the day of discharge by dedicated independent assessor Daily measurement until the day of discharge the type and dose of analgesic requirement is also documented

  2. Hospital stay

    Time frame: through study completion, an average of 1 year

    The number of days that patient stayed in hospital

  3. Time (hours) for Operative

    Time frame: Up to 24 hours

    The Time measured by hours from start of operation after general anesthesia until end of the operation

  4. Quality of life assessment by SF36

    Time frame: From date of operation on every followup appointment until 24 months after operation

    As measured by SF 36

  5. Mortality

    Time frame: 30 days after procedure

  6. Overall Survival

    Time frame: up to 5 years after operation

  7. Recurrence

    Time frame: up to 5 years after operation

  8. Disease free survival

    Time frame: up to 5 years after operation

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Acronym: LGE

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
May 2, 2017
Registry last updated
Jul 23, 2019

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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