Liver Cancer Clinical Trial
Official title:
Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy
NCT number | NCT06130436 |
Other study ID # | PRIC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 25, 2023 |
Est. completion date | September 2025 |
Our primary aim is to investigate whether perioperative remote ischemic conditioning (PRIC) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.
Status | Recruiting |
Enrollment | 135 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients undergoing hepatectomy under general anesthesia - American Society of Anesthesiology (ASA) grade of II ~ III - Male and female patients, age 25 to 75 years - New York Heart Association (NYHA) grade of I ~ III Exclusion Criteria: - Patients with limb deformity or peripheral vascular disease affecting upper limb function - Patients with a medical history of nervous system, immune system and mental illness - Patients who have received hepatectomy in the past, have important organ diseases or have undergone surgical treatment recently - Patients who have recently used anti-inflammatory analgesics, anticoagulants, hormone drugs, immunosuppressants, and ATP-sensitive K-channel blockers (KATP) - Preoperative severe renal insufficiency (serum creatinine > 442 umol/L, with or without serum potassium > 6.5 mmol/L, or the clinician-recognized need for renal replacement therapy), liver insufficiency (Child-Pugh grade C) - Patients and/or their family members refuse to participate in the program |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital, Chongqing Medical University | Chongqing |
Lead Sponsor | Collaborator |
---|---|
The Second Affiliated Hospital of Chongqing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alanine aminotransferase (ALT) | The levels of ALT in perioperative period | 7 days | |
Secondary | Aspartate aminotransferase (AST) | The levels of AST in perioperative period | 7 days | |
Secondary | Total bilirubin (TBIL) | The levels of TBIL in perioperative period | 7 days | |
Secondary | International normalized ratio (INR) | The levels of INR in perioperative period | 7 days | |
Secondary | Albumin (ALB) | The levels of ALB in perioperative period | 7 days | |
Secondary | Tumor necrosis factor-a (TNF-a) | The levels of TNF-a in perioperative period | 7 days | |
Secondary | Malondialdehyde (MDA) | The levels of MDA in perioperative period | 7 days | |
Secondary | Heme oxygenase-1 (HO-1) | The levels of HO-1 in perioperative period | 7 days | |
Secondary | Nuclear Factor-?B (NF-?B) | The levels of NF-?B in perioperative period | 7 days | |
Secondary | High mobility group box1 (HMGB1) | The levels of HMGB1 in perioperative period | 7 days | |
Secondary | Platelet | The levels of platelet in perioperative period | 7 days | |
Secondary | White blood cell (WBC) | The levels of WBC in perioperative period | 7 days | |
Secondary | Neutrophil granulocyte percentage | The levels of neutrophil granulocyte percentage in perioperative period | 7 days | |
Secondary | Time to gastrointestinal tolerance | Gastrointestinal tolerance was defined as transanal or stoma defecation and oral dietary tolerance. | 7 days | |
Secondary | Prolonged postoperative ileus | Prolonged postoperative ileus was diagnosed if patients met two or more of the following conditions on or after postoperative day 4: inability to tolerate the oral diet over the past 24 h, nausea or vomiting, without flatus over the past 24 h, abdominal distension or radiological evidence of intestinal distension without mechanical intestinal obstruction. | 7 days | |
Secondary | Rate of postoperative complications | The postoperative complications were recorded using the Clavien-Dindo classification system and included: nausea or vomiting, abdominal distension, anastomotic leakage, new pulmonary infection, poor wound healing, cognitive dysfunction, unplanned reoperation, and 30-day readmission rate. | 30 days |
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