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Pilot clinical evaluation of a novel dual-operator endoscopic technique (TECS) for gastrointestinal tumor resection: Technical feasibility, safety, and learning curve analysis

Feasibility and safety of a novel thin therapeutic endoscope combination surgery for gastrointestinal tumors: A retrospective cohort study - TECS study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057158
Enrollment
43
Registered
2025-02-27
Start date
2025-02-01
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

Gastrointestinal tumor

Interventions

None listed

Sponsors

Nagasaki Harbor Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients included in the study were aged 18 years or older, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and had been diagnosed with an epithelial tumor of the stomach or large intestine deemed suitable for ESD based on preoperative endoscopic evaluation. The TECS eligibility criteria were the same as those for ESD, which were based on the treatment guidelines for gastrointestinal cancer in Japan [12,13]. The size, shape, location, and fibrosis of the tumor were not taken into account. Only patients who received a full explanation of the procedure, its associated risks, and alternative treatment options and who provided written informed consent, were included in the study.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had incomplete clinical records regarding preoperative assessment, procedural details, or postoperative course; if there was a discrepancy between the endoscopic diagnosis and the final pathological findings (e.g., no tumor identified); if adequate sedation could not be achieved; or if they declined to provide written informed consent despite receiving a full explanation of the procedure and associated risks.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure was defined as the success rate of the procedure, which was defined as the completion of the treatment procedure from start to finish using only TECS.

Secondary

MeasureTime frame
Secondary outcomes included the en bloc resection rate, procedure time, resection speed, and rate of adverse events.

Countries

Japan

Contacts

Public ContactTakuma Okamura

Nagasaki Harbor Medical Center gastroenterology

taku.okamu1002@gmail.com0958223251

Outcome results

None listed

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