Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

NCT07540975 | Not Yet Recruiting DMC

• 1 other identifier: 2021-1708
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  From postoperative day 0 through postoperative day 3

Secondary Outcomes (7)

• 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

Study Arms (2)

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.

Other: No Insulin Infusion (Standard Monitoring Only)

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.

Drug: Insulin Infusion

Interventions

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.

Standard Insulin Infusion Group

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.

No Insulin Infusion Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dae Wook Hwang: lead

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

Insulin Infusion Systems

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Dae Wook Hwang

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirang Lee, Dr

CONTACT

+81-10-3390-5026; effly5026@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)