Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

Liver Cancer Clinical Trial

Official title:

Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06130436
• Other study ID #: PRIC
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: He Huang, ph.D
• Phone: 86-13708385559
• Email: huanghe[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hemangioma
• Hepatectomy
• Hepatic Hemangioma
• Hepatolithiasis
• Liver Cancer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

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