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NCT Number: NCT07540975

Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3)

    Time frame: From postoperative day 0 through postoperative day 3

Secondary outcomes

  1. Mean Blood Glucose Level on Postoperative Day 0

    Time frame: Postoperative day 0

  2. Mean Blood Glucose Level on Postoperative Day 1

    Time frame: Postoperative day 1

  3. Mean Blood Glucose Level on Postoperative Day 2

    Time frame: Postoperative day 2

  4. Mean Blood Glucose Level on Postoperative Day 3

    Time frame: Postoperative day 3

  5. Postoperative Blood Glucose Variability

    Time frame: From postoperative day 0 through postoperative day 3

  6. Incidence of Hypoglycemia

    Time frame: From postoperative day 0 through postoperative day 3

  7. Incidence of Surgical Site Infection (SSI)

    Time frame: Within 3 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Mirang Lee, Dr

CONTACT

[email protected]

+81-10-3390-5026

Sponsors and collaborators

Lead sponsor

Dae Wook Hwang

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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