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Safety and efficacy of adhesion barrier products on the inferor surface of the liver in laparoscopic gastrectomy

Safety and efficacy of adhesion barrier products on the inferor surface of the liver in laparoscopic gastrectomy - Safety and efficacy of adhesion barrier products on the inferor surface of the liver in laparoscopic gastrectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051321
Enrollment
100
Registered
2023-06-11
Start date
2021-03-31
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

gastric cancer or esophagogastric junction cancer

Interventions

None listed

Sponsors

Osaka International Cancer Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients aged 20 years or older at the time of informed consent. 2)Histologically diagnosed with cancer 3) Patients with ECOG Performance Status of 0-1. 4)Patients who have preserved heart, lung, liver, kidney and bone marrow functions and who meet all of the following laboratory test values. a. Renal function: BUN less than 1.5 times the facility's upper limit of normal values Serum creatinine level less than 1.5 times the facility's upper limit of normal values b. Liver function: AST (GOT) less than 1.5 times the facility's upper limit of normal values ALT (GPT) less than 1.5 times the facility's upper limit of normal values Serum total bilirubin level less than 1.5 times the facility's upper limit of normal values c. Blood: Neutrophils 1,500/mm3 or more Platelet count 100,000/mm3 or more Hb 8.0 g/dL or more d. Cardiac function Electrocardiogram: no serious abnormalities e. Lung function Pulmonary function: arterial blood oxygen saturation (Sp02) more than 94% (without oxygen administration) 5) Patients with no other active double cancers (including hematologic malignancies). 6)Patients who have been informed of their disease name and condition, who have received an explanation of this study, and who are able to obtain written consent after understanding the content.

Exclusion criteria

Exclusion criteria: 1) Patients with uncontrolled infections (including active tuberculosis) 2) Patients with a history of hypersensitivity to anti-adhesion agents 3) Pregnant women, lactating women, or patients who may be pregnant. 4) Patients with uncontrolled diabetes 5) Patients who have a history of upper abdominal surgery (including laparoscopic surgery) in the past, patients who have a history of open surgery 6) Patients who are currently using or have a history of long-term use of steroid hormones 7) Other patients who are judged to be ineligible by the principal investigator or co-investigator

Design outcomes

Primary

MeasureTime frame
Incidence rate of postoperative intra-abdominal infections (anastomotic leakage, pancreatic fistula, intra-abdominal abscess) of Clavien-Dindo classification Grade II or higher

Countries

Japan

Contacts

Public ContactKei Yamamoto

Osaka International Cancer Institute Gastroenterological Surgery

kei.yamamoto@oici.jp+81-6-6945-1181

Outcome results

None listed

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