Clinical trial: Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy (NCT01411176)

Eligibility criteria:
Inclusion Criteria:

        inpatients or outpatients of either sex who require therapeutic upper gastrointestinal
        endoscopy (EMR or ESD) and meet the criteria (1)-(4) below will be enrolled in the study.
        Patients have to provide written informed consent for voluntary participation in the study.
        The criteria (2) and (3) will be confirmed by the endoscopic observation just before
        starting the intended treatment.

          1. Patients with an early gastric cancer located in the lower third of the stomach, who
             require therapeutic upper gastrointestinal endoscopy (EMR or ESD) (except for those
             with an intended treatment by using a scope of <9 mm in diameter)

          2. Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in
             size, no ulcer finding

          3. Patients with a single intended lesion for the treatment

          4. Patients who are older than 20 years at the time of consent

        Exclusion Criteria:

        Patients who meet any of the following criteria will be excluded from the study beforehand.
        The criteria (3) to (5) will be confirmed by the endoscopic observation just before
        starting the intended treatment.

          1. Patients with a history of surgery to the upper gastrointestinal tract

          2. Patients who require emergency endoscopy

          3. Patients with severe gastric stenosis or deformation which makes observation of
             gastric peristalsis difficult

          4. Patients who require emergency endoscopic treatment except for the intended lesion

          5. Patients with a lesion extended to the pyloric ring

          6. Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)

          7. Patients with pacemaker

          8. Patients with known bleeding tendency or Patients with difficulty of antithrombogenic
             agents withdrawal

          9. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil

         10. Patients with contraindications to glucagon

         11. Patients with contraindications to benzodiazepines, pethidine hydrochloride, and
             epinephrine

         12. Pregnant or lactating women, women of childbearing potential, or women who plan to
             become pregnant during the study

         13. Patients who have received other investigational drugs within four months before
             consent or who are participating in other clinical studies

         14. Patients otherwise ineligible for participation in the study in the investigator's
             opinion
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment