Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

NCT06130436 | Completed DMC

• 1 other identifier: PRIC
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Hemangioma; Liver Cancer; Hepatolithiasis; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• Alanine aminotransferase (ALT)

  The levels of ALT in perioperative period

  7 days

Secondary Outcomes (15)

• Aspartate aminotransferase (AST)

  7 days

• Total bilirubin (TBIL)

  7 days

• International normalized ratio (INR)

  7 days

• Albumin (ALB)

  7 days

• Tumor necrosis factor-α (TNF-α)

  7 days

Study Arms (3)

Sham-Remote Ischemic Conditioning

SHAM COMPARATOR

Sham remote ischemic conditioning (Sham-RIC) is applied in the perioperative using an automated Sham-RIC device.

Device: Sham-Remote Ischemic Conditioning

Remote Ischemic Conditioning Once Daily

ACTIVE COMPARATOR

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 Twice Daily

ACTIVE COMPARATOR

Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device twice daily.

Device: Remote Ischemic Conditioning Twice Daily

Interventions

Sham-Remote Ischemic Conditioning DEVICE

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.

Sham-Remote Ischemic Conditioning

Remote Ischemic Conditioning Once Daily DEVICE

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.

Remote Ischemic Conditioning Once Daily

Remote Ischemic Conditioning Twice Daily DEVICE

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.

Remote Ischemic Conditioning Twice Daily

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, China

Location

Related Publications (1)

• Tian C, Tian H, Li W, Chen J, Guo Q, Duan G, Huang H. Effects of Remote Ischemic Conditioning on Postoperative Recovery After Hepatectomy: A Randomised Controlled Trial. Liver Int. 2025 Mar;45(3):e70041. doi: 10.1111/liv.70041.

  PMID: 39982031 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• He Huang, ph.D

  The Second Affiliated Hospital, Chongqing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, patient-assessor blinded, sham-controlled trial

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 14, 2023
• Study Start: November 2, 2023
• Primary Completion: July 29, 2024
• Study Completion: August 9, 2024
• Last Updated: August 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 2 years following article publication.
• Access Criteria: To gain access data requestors will need to sign a data processing agreement.

Locations

CN (1)