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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham-Remote Ischemic Conditioning | Sham Comparator | Sham remote ischemic conditioning (Sham-RIC) is applied in the perioperative using an automated Sham-RIC device. |
|
| Remote Ischemic Conditioning Once Daily | Active Comparator | Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine aminotransferase (ALT) | The levels of ALT in perioperative period | 7 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| He Huang, ph.D | The Second Affiliated Hospital, Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, Chongqing Medical University | Chongqing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39982031 | Derived | 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. |
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The individual participant data for this study is available from the sponsor on reasonable request through email.
Beginning 3 months and ending 2 years following article publication.
To gain access data requestors will need to sign a data processing agreement.
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Prospective, randomized, patient-assessor blinded, sham-controlled trial
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|
| 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 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. |
|
| 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 |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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