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The goal of this randomized non-inferiority clinical trial is to evaluate whether routine postoperative insulin infusion can be safely omitted in preoperative non-diabetic adult patients undergoing pancreatectomy for periampullary or pancreatic tumors. The primary purpose is to determine whether withholding insulin infusion provides comparable glycemic control while reducing treatment-related burden and adverse events.
The main questions it aims to answer are:
Researchers will compare a no-insulin infusion group (intervention arm) with a standard insulin infusion group (control arm) to determine whether avoiding routine insulin infusion maintains comparable glycemic control while improving safety and patient comfort.
Participants will:
This study aims to establish evidence-based postoperative glucose management strategies for non-diabetic patients undergoing pancreatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Insulin Infusion Group | Experimental | Participants assigned to this group will not receive routine postoperative insulin infusion following pancreatectomy. Blood glucose will be monitored four times daily. If fasting blood glucose exceeds 180 mg/dL for two consecutive days, rescue insulin therapy will be initiated according to institutional protocol. All other perioperative care will follow standard postoperative management. |
|
| Standard Insulin Infusion Group | Active Comparator | Participants assigned to this group will receive continuous insulin infusion following pancreatectomy according to institutional protocol. Blood glucose will be monitored every 2 hours initially, with adjustment of insulin infusion rate to maintain target glucose levels (typically 140-180 mg/dL). Insulin infusion will be continued until postoperative day 2 (9 AM), unless discontinued earlier due to hypoglycemia or clinical indication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Infusion | Drug | Continuous intravenous insulin infusion administered postoperatively according to institutional protocol. Blood glucose levels are monitored at regular intervals, and the infusion rate is adjusted to maintain target glucose levels (typically 140-180 mg/dL). Insulin infusion is continued until postoperative day 2 (9 AM) unless discontinued earlier due to hypoglycemia or clinical indication. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3) | From postoperative day 0 through postoperative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Blood Glucose Level on Postoperative Day 0 | Postoperative day 0 | |
| Mean Blood Glucose Level on Postoperative Day 1 | Postoperative day 1 | |
| Mean Blood Glucose Level on Postoperative Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mirang Lee, Dr | Contact | +81-10-3390-5026 | effly5026@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dae Wook Hwang | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
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| No Insulin Infusion (Standard Monitoring Only) | Other | Postoperative management without routine insulin infusion. Blood glucose levels are monitored four times daily. If fasting blood glucose exceeds 180 mg/dL for two consecutive days, rescue insulin therapy is initiated according to institutional protocol. All other perioperative care follows standard postoperative management. |
|
| Postoperative day 2 |
| Mean Blood Glucose Level on Postoperative Day 3 | Postoperative day 3 |
| Postoperative Blood Glucose Variability | From postoperative day 0 through postoperative day 3 |
| Incidence of Hypoglycemia | From postoperative day 0 through postoperative day 3 |
| Incidence of Surgical Site Infection (SSI) | Within 3 months after surgery |
| D004864 |
| Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |