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Completed

NCT Number: NCT02216110

Endoscopic Submucosal Dissection Versus Gastrectomy

Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic submucosal dissection (ESD) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. However, there are limited data regarding the long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Soonchunhyang University Hospital

Seoul, South Korea

About this study

The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea, the detection rate of EGC has increased with mass screening for the prevention of gastric cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional lymph node metastasis. The presence of lymph node metastasis has been reported to range from 2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year survival rate above 90%.

In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the basis of large scale retrospective data. Thereafter, the result was adopted as expanded criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor recurrence rate.

Although curative resection is pathologically achieved by ESD, post-resection surveillance is needed to confirm the presence of nodal metastasis. Recently, several studies reported that 5-year overall and disease-specific survival rate were highly favorable in EGC patients who underwent curative ESD. However, there is no comparative study about long-term outcomes after ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate, tumor recurrence, development of metachronous cancers between ESD and surgery groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • differentiated type mucosal cancer without ulceration, regardless of tumor size
  • differentiated type mucosal cancer with ulceration ≤ 3 cm in diameter
  • superficial (SM1 < 500 μm) submucosal cancer ≤ 3 cm in diameter
  • undifferentiated type mucosal cancer without ulceration ≤ 2 cm in diameter

Exclusion criteria

  • early gastric cancer in a remnant stomach
  • gastrectomy due to metachronous lesions during follow-up period
  • post-ESD additional surgery due to high risk of lymph node metastasis or the possibility of residual tumor

Treatment and study plan

Surgery

Procedure

Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection

Primary outcomes

  1. Patient's death

    Time frame: up to 5 years

Secondary outcomes

  1. Tumor recurrence

    Time frame: up to 5 years

  2. Development of metachronous cancers

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer

Important dates

Study start
2003
Primary completion
2014
Study completion
2015
First posted
Aug 13, 2014
Registry last updated
May 20, 2015

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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