Hepatic HemangiomaNCT06130436
Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy
A study testing Remote Ischemic Conditioning Once Daily and Remote Ischemic Conditioning Twice Daily in people with Hepatic Hemangioma and Liver Cancer, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hepatic Hemangioma, Liver Cancer, Hepatolithiasis
- What is being tested?
- Remote Ischemic Conditioning Once Daily and Remote Ischemic Conditioning Twice Daily
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2023to 9 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Chongqing Medical University
Chongqing
About this study
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.
Read the 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.
- Conditions
- Hepatic Hemangioma, Liver Cancer, Hepatolithiasis, Hepatectomy
- Being tested
- Sham-Remote Ischemic Conditioning, Remote Ischemic Conditioning Once Daily, Remote Ischemic Conditioning Twice Daily
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham-Remote Ischemic ConditioningDevice
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 DailyDevice
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 DailyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham-Remote Ischemic Conditioning | Sham comparator | Sham remote ischemic conditioning (Sham-RIC) is applied in the perioperative using an automated Sham-RIC device. Receives: 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. Receives: 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. Receives: Device: Remote Ischemic Conditioning Twice Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine aminotransferase (ALT)
The levels of ALT in perioperative period
Measured: 7 days
Secondary outcomes (15)
Aspartate aminotransferase (AST)
The levels of AST in perioperative period
Measured: 7 days
Total bilirubin (TBIL)
The levels of TBIL in perioperative period
Measured: 7 days
International normalized ratio (INR)
The levels of INR in perioperative period
Measured: 7 days
Albumin (ALB)
The levels of ALB in perioperative period
Measured: 7 days
Tumor necrosis factor-α (TNF-α)
The levels of TNF-α in perioperative period
Measured: 7 days
Malondialdehyde (MDA)
The levels of MDA in perioperative period
Measured: 7 days
Heme oxygenase-1 (HO-1)
The levels of HO-1 in perioperative period
Measured: 7 days
Nuclear Factor-κB (NF-κB)
The levels of NF-κB in perioperative period
Measured: 7 days
High mobility group box1 (HMGB1)
The levels of HMGB1 in perioperative period
Measured: 7 days
Platelet
The levels of platelet in perioperative period
Measured: 7 days
White blood cell (WBC)
The levels of WBC in perioperative period
Measured: 7 days
Neutrophil granulocyte percentage
The levels of neutrophil granulocyte percentage in perioperative period
Measured: 7 days
Time to gastrointestinal tolerance
Gastrointestinal tolerance was defined as transanal or stoma defecation and oral dietary tolerance.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start2 Nov 2023
- Primary completion29 Jul 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic HemangiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, patient-assessor blinded, sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Huang, ph.D, Study chair, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130436
- Sponsor's protocol ID
- PRIC
- Status last verified
- Oct 2023
- First submitted
- 2 Nov 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Publications
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.
PubMed 39982031
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy
- ClinicalTrials.gov ID
- NCT06130436
- Acronym / sponsor ID
- PRIC
- Conditions
- Hepatic Hemangioma, Liver Cancer, Hepatolithiasis, Hepatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, patient-assessor blinded, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Sham-Remote Ischemic Conditioning | Sham comparator | Device: Sham-Remote Ischemic ConditioningSham remote ischemic conditioning (Sham-RIC) is applied in the perioperative using an automated Sham-RIC device. |
| Remote Ischemic Conditioning Once Daily | Active comparator | Device: Remote Ischemic Conditioning Once DailyRemote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device once daily. |
| Remote Ischemic Conditioning Twice Daily | Active comparator | Device: Remote Ischemic Conditioning Twice DailyRemote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device twice daily. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham-Remote Ischemic ConditioningSham-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. | Device | Sham-Remote Ischemic Conditioning |
| Remote Ischemic Conditioning Once DailyRemote 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. | Device | Remote Ischemic Conditioning Once Daily |
| Remote Ischemic Conditioning Twice DailyRemote 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. | Device | Remote Ischemic Conditioning Twice Daily |
Primary outcome
Alanine aminotransferase (ALT)
Time frame: 7 days
The levels of ALT in perioperative period
15 secondary outcomes
Aspartate aminotransferase (AST)
Time frame: 7 days
Total bilirubin (TBIL)
Time frame: 7 days
International normalized ratio (INR)
Time frame: 7 days
Albumin (ALB)
Time frame: 7 days
Tumor necrosis factor-α (TNF-α)
Time frame: 7 days
Malondialdehyde (MDA)
Time frame: 7 days
Heme oxygenase-1 (HO-1)
Time frame: 7 days
Nuclear Factor-κB (NF-κB)
Time frame: 7 days
High mobility group box1 (HMGB1)
Time frame: 7 days
Platelet
Time frame: 7 days
White blood cell (WBC)
Time frame: 7 days
Neutrophil granulocyte percentage
Time frame: 7 days
Time to gastrointestinal tolerance
Time frame: 7 days
Prolonged postoperative ileus
Time frame: 7 days
Rate of postoperative complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 39982031Tian 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.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Huang, ph.D study chair
The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning Once Daily and Remote Ischemic Conditioning Twice Daily in people with Hepatic Hemangioma and Liver Cancer, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alanine aminotransferase (ALT) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.