A phase 2 study of endoscopic submucosal dissection (ESD) using a new Single Use Electrosurgical Knife for early esophageal or gastric cancer

A phase 2 study of endoscopic submucosal dissection (ESD) using a new Single Use Electrosurgical Knife for early esophageal or gastric cancer - A phase 2 study of ESD using a new Single Use Electrosurgical Knife

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004941

Enrollment

103

Registered

2011-02-01

Start date

2011-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early esophageal and gastric cancer

Interventions

endoscopic submucosal dissection using a new Single Use Electrosurgical Knife

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Primary and single gastric or esophageal cancer. 2) Endoscopic findings of each tumor as follows. Gastric cancer: 2)-1 Histologically proven differentiated adenocarcinoma by biopsy. A mixed case of undifferentiated components is not eligible. 2)-2 Size of tumor is <=2cm without ulcer or ulcer scar. 2)-3 Depth of invasion is clinical M. Esophageal cancer: 2)-1 Size of tumor is <=3cm 2)-2 Depth of invasion is clinical m1 or m2. 2)-3 Histologically proven squamous cell carcinoma or basaloid carcinoma by biopsy. 3) En-bloc resection is possible with ESD. 4) The possibility of stenosis after ESD is low. i.e. the location of each tumor meets the all following criterion. Gastric cancer: 4)-1 Tumor invasion of the pylorus or cardia is not observed. Esophageal cancer: 4)-1 Tumor is located within the thoracic esophagus 4)-2 Circularity is two-thirds or less. 5) Aged 20 to 75 years old. 6) PS (ECOG) of 0 or 1. 7) Past treatments as follows. Gastric cancer: No endoscopic treatment for gastric cancer Esophageal cancer: No endoscopic treatment for esophageal cancer 8) No prior treatment of surgery, chemotherapy (including endocrinotherapy) or radiation therapy for cancer. 9) Sufficient organ functions. 10) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Impossible to discontinue anticoagulant or antiplatelet medications. 2) Women during pregnancy or breast-feeding. 3) Psychosis. 4) Systemic steroids medication. 5) Active bacterial or fungous infection. 6) History of myocardial infarction or unstable angina pectoris within three months. 7) Uncontrollable hypertension. 8) Uncontrollable diabetes mellitus or administration of insulin. 9) Severe respiratory disease requiring continuous oxygen therapy.

Design outcomes

Primary

Measure	Time frame
Proportion of serious adverse events related to ESD	—

Secondary

Measure	Time frame
Proportion of en-bloc resection, Adverse events	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026