Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

Effects of Insulin Intervention After Pancreatectomy in Preoperative Non-diabetic Patients : Randomized Non-inferiority Clinical Trial

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:

• Does omission of postoperative insulin infusion result in non-inferior mean blood glucose levels through postoperative day (POD) 3 compared to standard insulin infusion?
• Does omission of insulin infusion reduce the incidence of hypoglycemia without increasing postoperative complications, including surgical site infection within 3 months?

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:

• Undergo pancreatectomy and be randomly assigned (1:1) to either receive standard insulin infusion or no routine insulin infusion postoperatively
• Have blood glucose monitored using intermittent testing and continuous glucose monitoring (flash glucose monitoring system)
• Receive protocol-based glycemic management, including rescue insulin if hyperglycemia occurs or discontinuation if hypoglycemia develops
• Be followed for up to 3 months postoperatively to assess glycemic outcomes, hypoglycemic events, surgical site infection, and other postoperative complications
• Complete a questionnaire assessing discomfort related to glucose monitoring and insulin administration

This study aims to establish evidence-based postoperative glucose management strategies for non-diabetic patients undergoing pancreatectomy.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatectomy; Postoperative Hyperglycemia
• Intervention / Treatment: Other: No Insulin Infusion (Standard Monitoring Only); Drug: Insulin Infusion

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mirang Lee, Dr; Phone Number: +81-10-3390-5026; Email: effly5026@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 05505
    • Asan Medical Center
    • Contact: Seo Hyun Kim, Study Coordinator; Phone Number: +82-2-3010-8667; Email: ksh6136@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 80 years
• Patients without a prior diagnosis of diabetes mellitus
• Patients scheduled to undergo pancreatectomy for periampullary tumors or pancreatic tumors
• Ability to understand the study and provide written informed consent

Exclusion Criteria:

• Patients diagnosed with pancreatic adenocarcinoma
• Patients undergoing total pancreatectomy
• Patients undergoing hepatopancreatoduodenectomy (HPD) or with a history of prior hepatectomy
• Patients with severe comorbidities (e.g., liver cirrhosis, chronic kidney disease, or heart failure)
• Patients currently enrolled in another clinical trial that may interfere with this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No Insulin Infusion Group; 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.	Other: No Insulin Infusion (Standard Monitoring Only); 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.
Active Comparator: Standard Insulin Infusion Group; 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.	Drug: Insulin Infusion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Dae Wook Hwang
• Investigators: Principal Investigator: Dae Wook Hwang, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Therapy; Surgical Equipment; Equipment and Supplies; Artificial Organs; Drug Delivery Systems; Infusion Pumps; Insulin Infusion Systems
• Other Study ID Numbers: 2021-1708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No