Clinical trial NCT06130436: Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy
Official title: Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Hemangioma
Liver Cancer
Hepatolithiasis
Hepatectomy
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 135
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, patient-assessor blinded, sham-controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Remote Ischemic Conditioning (RIC) can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. This protection can be applied prior to or during a prolonged ischemic event as remote ischemic pre-conditioning (RIPreC) and per-conditioning (RIPerC), respectively, or immediate after reperfusion as remote ischemic post-conditioning (RIPostC).

RIC is a non-pharmacologic and non-invasive treatment without noticeable discomfort, commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion. However, whether perioperative remote ischemic conditioning (PRIC) can improve postoperative recovery in patients undergoing hepatectomy has never been investigated in a randomized controlled trial.

Eligibility criteria: 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

Primary outcomes:
measure: Alanine aminotransferase (ALT)
timeFrame: 7 days
Secondary outcomes:
measure: Aspartate aminotransferase (AST)
timeFrame: 7 days
measure: Total bilirubin (TBIL)
timeFrame: 7 days
measure: International normalized ratio (INR)
timeFrame: 7 days
measure: Albumin (ALB)
timeFrame: 7 days
measure: Tumor necrosis factor-α (TNF-α)
timeFrame: 7 days
measure: Malondialdehyde (MDA)
timeFrame: 7 days
measure: Heme oxygenase-1 (HO-1)
timeFrame: 7 days
measure: Nuclear Factor-κB (NF-κB)
timeFrame: 7 days
measure: High mobility group box1 (HMGB1)
timeFrame: 7 days
measure: Platelet
timeFrame: 7 days
measure: White blood cell (WBC)
timeFrame: 7 days
measure: Neutrophil granulocyte percentage
timeFrame: 7 days
measure: Time to gastrointestinal tolerance
timeFrame: 7 days
measure: Prolonged postoperative ileus
timeFrame: 7 days
measure: Rate of postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
Study officials:
affiliation: The Second Affiliated Hospital, Chongqing Medical University
name: He Huang, ph.D
role: STUDY_CHAIR
References: