A Study to Evaluate the Safety and Effectiveness of Negative Pressure Wound Therapy for Bile Leakage After Liver Surgery

An Exploratory Single-Arm Clinical Study Evaluating the Safety and Efficacy of Negative Pressure Wound Therapy (NPWT) in the Management of Bile Leakage Following Hepatectomy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs062250045

Enrollment

Registered

2025-08-13

Start date

2025-10-01

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

Bile leakage after hepatectomy

Interventions

Negative pressure wound therapy (NPWT) will be applied to patients with bile leakage after hepatectomy by connecting the NPWT device to the indwelling abdominal drain. A negative pressure of -125 +/-

NPWT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with bile leakage following hepatectomy. 2.Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2. 3.Patients aged 18 years or older at the time of providing informed consent. 4.Patients with preserved major organ function (including bone marrow, liver, and kidneys) based on the following laboratory data at enrollment: A) White blood cell count greater than or equal to 3,000/mm3 B) Hemoglobin greater than or equal to 7.0 g/dL C) Platelet count greater than or equal to 30,000/mm3 D) Total bilirubin less than or equal to 5.0 mg/dL E) Serum creatinine less than or equal to 3.0 mg/dL 5.Patients who are able to understand the study and have voluntarily provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe ischemic heart disease classified as NYHA Class III or higher. 2. Patients with advanced liver cirrhosis (Child-Pugh Class C). 3. Patients with dyspnea requiring oxygen therapy due to interstitial pneumonia, pulmonary fibrosis, or similar pulmonary conditions. 4. Patients with psychiatric disorders or psychiatric symptoms that are deemed to interfere with participation in the study. 5. Patients who are judged by the principal investigator or sub-investigators to be unsuitable for participation in this study for any other reason.

Design outcomes

Primary

Measure	Time frame
The proportion of patients in which the total drainage duration for bile leakage was 14 days or less	—

Secondary

Measure	Time frame
1.Total duration of drainage for bile leakage 2.Total length of hospital stay related to bile leakage treatment 3.Proportion of patients requiring surgical intervention for bile leakage 4.Proportion of patients who died during treatment for bile leakage 5.Success rate of bile leakage treatment using negative pressure wound therapy (NPWT) 6.Proportion of patients who did not undergo endoscopic nasobiliary drainage (ENBD) for bile leakage 7.Proportion of patients with positive bile cultures	—

Measure

Time frame

1.Total duration of drainage for bile leakage 2.Total length of hospital stay related to bile leakage treatment 3.Proportion of patients requiring surgical intervention for bile leakage 4.Proportion of patients who died during treatment for bile leakage 5.Success rate of bile leakage treatment using negative pressure wound therapy (NPWT) 6.Proportion of patients who did not undergo endoscopic nasobiliary drainage (ENBD) for bile leakage 7.Proportion of patients with positive bile cultures

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Contacts

Public ContactTsuyoshi Kobayashi

Hiroshima university hospital

tsukoba@hiroshima-u.ac.jp+81-82-257-5222

Outcome results

None listed

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