Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

Not Applicable

Completed

• Conditions: Liver Cancer; Hepatolithiasis; Hepatectomy; Hepatic Hemangioma
• Interventions: Device: Remote Ischemic Conditioning Twice Daily; Device: Remote Ischemic Conditioning Once Daily; Device: Sham-Remote Ischemic Conditioning

• Registration Number: NCT06130436
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-11-02
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Primary Completion: 2024-07-29
• Study Completion: 2024-08-09
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Conditioning Twice Daily	Remote Ischemic Conditioning Twice Daily	Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device twice daily.
Remote Ischemic Conditioning Once Daily	Remote Ischemic Conditioning Once Daily	Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device once daily.
Sham-Remote Ischemic Conditioning	Sham-Remote Ischemic Conditioning	Sham remote ischemic conditioning (Sham-RIC) is applied in the perioperative using an automated Sham-RIC device.

Primary Outcome Measures

Name	Time	Method
Alanine aminotransferase (ALT)	7 days	The levels of ALT in perioperative period

Secondary Outcome Measures

Name	Time	Method
Platelet	7 days	The levels of platelet in perioperative period
Nuclear Factor-κB (NF-κB)	7 days	The levels of NF-κB in perioperative period
Rate of postoperative complications	30 days	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.
Total bilirubin (TBIL)	7 days	The levels of TBIL in perioperative period
White blood cell (WBC)	7 days	The levels of WBC in perioperative period
Aspartate aminotransferase (AST)	7 days	The levels of AST in perioperative period
Malondialdehyde (MDA)	7 days	The levels of MDA in perioperative period
Heme oxygenase-1 (HO-1)	7 days	The levels of HO-1 in perioperative period
High mobility group box1 (HMGB1)	7 days	The levels of HMGB1 in perioperative period
Neutrophil granulocyte percentage	7 days	The levels of neutrophil granulocyte percentage in perioperative period
Tumor necrosis factor-α (TNF-α)	7 days	The levels of TNF-α in perioperative period
International normalized ratio (INR)	7 days	The levels of INR in perioperative period
Albumin (ALB)	7 days	The levels of ALB in perioperative period
Time to gastrointestinal tolerance	7 days	Gastrointestinal tolerance was defined as transanal or stoma defecation and oral dietary tolerance.
Prolonged postoperative ileus	7 days	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.

Trial Locations

Locations (1)

The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, China