Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

Summary

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.

Conditions

• Postoperative Hyperglycemia
• Pancreatectomy

Interventions

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.

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.

Sponsors & Collaborators

• Dae Wook Hwang

  lead OTHER

Principal Investigators

• Dae Wook Hwang · Asan Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-18

Primary Completion

2029-12-31

Completion

2030-03-31

Countries

• South Korea

Study Locations