Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatectomy; Liver Cancer; Hepatolithiasis; Hepatic Hemangioma
• Intervention / Treatment: Device: Sham-Remote Ischemic Conditioning; Device: Remote Ischemic Conditioning Once Daily; Device: Remote Ischemic Conditioning Twice Daily

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 Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: He Huang, ph.D; Phone Number: 86-13708385559; Email: huanghe@cqmu.edu.cn
• Study Contact Backup: Name: Chun Tian, ph.D; Phone Number: 86-15723059158; Email: tianchun314@163.com

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • The Second Affiliated Hospital, Chongqing Medical University
    • Contact: He Huang, ph.D; Phone Number: 86-13708385559; Email: huanghe@cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham-Remote Ischemic Conditioning; Sham remote ischemic conditioning (Sham-RIC) is applied in the perioperative using an automated Sham-RIC device.	Device: Sham-Remote Ischemic Conditioning; Sham-Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.
Active Comparator: Remote Ischemic Conditioning Once Daily; Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device once daily.	Device: Remote Ischemic Conditioning Once Daily; Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, the morning of the postoperative day 1, the morning of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg. Sham-Remote Ischemic Conditioning (at the time points of 30 min after surgery, the afternoon of the postoperative day 1, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.
Active Comparator: Remote Ischemic Conditioning Twice Daily; Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device twice daily.	Device: Remote Ischemic Conditioning Twice Daily; Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine aminotransferase (ALT)	The levels of ALT in perioperative period	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: He Huang, ph.D, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Hemangioma
• Other Study ID Numbers: PRIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email.
• IPD Sharing Time Frame: Beginning 3 months and ending 2 years following article publication.
• IPD Sharing Access Criteria: To gain access data requestors will need to sign a data processing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No