Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT04871204
Eligibility Criteria:
Inclusion Criteria:
1. Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer
2. Gastrectomy or esophagectomy with curative intent
3. ≥18 years of age
4. Signed informed consent
5. Able to comply with the procedures of the study protocol, in the opinion of the investigator
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, only after A. leaving a negative result on a highly sensitive pregnancy test, B. are using a highly effective method of contraception during treatment, and C. throughout the study.
Exclusion Criteria:
1. Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery
2. Complications leading to restrictions in postoperative oral intake
3. Advanced comorbidity with ASA score III or more
4. Bradycardia (defined as resting heart rate of under 60 beats per minute)
5. Chronic obstructive pulmonary disease
6. Chronic liver disease
7. Insulinoma
8. Kidney failure
9. Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine
10. Known or suspected allergy to octreotide
11. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
12. Pregnant or nursing female
13. Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04871204
Study Brief:
Protocol Section:
NCT04871204