Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery

Not Applicable

• Conditions: Diabetes; Pancreas Cancer

• Registration Number: NCT06774170
• Lead Sponsor: Dokuz Eylul University

Brief Summary

The primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months after PD on patient outcomes (mortality, rehospitalization and having surgery, wound site complications, bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arythmia, pneumonia, intraabdominal abscess, bleeding and pain) and the quality of life. The secondary aim of the study is to evaluate the factors affecting glucose levels in three months after PD by using data mining. Data mining will allow evaluation of all the factors affecting glucose levels by using detailed blood glucose predictors obtained through continuous glucose monitoring after PD. The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients with PD. The allocation ratio will be 1:1. Since being diagnosed as diabetes before surgery is an important variable, block randomization will be performed depending on whether the patients have the diagnosis of diabetes.

Detailed Description

The primary aim of the present study is to examine the effect of a "structured follow-up intervention" to be performed in the first three months after PD on blood glucose. The exploratory aim of the study is to examine the effect of the "structured follow-up intervention" to be performed in the first three months after PD on patient outcomes (mortality, rehospitalization and having surgery, wound site complications, bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arythmia, pneumonia, intraabdominal abscess, bleeding and pain) and the quality of life. The secondary aim of the study is to evaluate the factors affecting glucose levels in three months after PD by using data mining. Data mining will allow evaluation of all the factors affecting glucose levels by using detailed blood glucose predictors obtained through continuous glucose monitoring after PD. The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients with PD. The allocation ratio will be 1:1. Since being diagnosed as diabetes before surgery is an important variable, block randomization will be performed depending on whether the patients have the diagnosis of diabetes.

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-14
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-11-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

The inclusion criteria for the particioants were; being over 18 years of age, being a smartphone user compatible with the Dexcom G6 application, having an internet connection, having a Mini Mental Test result of over 22 points for educated individuals and over 19 points for uneducated individuals, being willing to participate in the study, and having undergone pancreaticoduodenectomy.

In the study, "able to swallow table" is not eligibility criteria due to tablet (medication) adherence is not assssed In the study, patients with and without preoperative diabetes mellitus type II were included in the sample. Block randomization was performed according to the presence of DM. Therefore, the presence of diabetes is not an exclusion criterion.

In the literature, thyroid disease has not been identified as an exclusion criterion in studies related to pancreatogenic diabetes. The endocrinologist involved in this project did not find it necessary to add thyroid disease as an exclusion criterion.

Exclusion Criteria

Exclusion criteria were; having developed sepsis after surgery, having been diagnosed with insulinoma, glycogonoma, ectopic ACTH syndrome before surgery, having been diagnosed with a psychiatric disease, clinical diagnosis of Alzheimer's Disease and being hospitalized.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	Three months	HbA1c
fasting blood glucose	Three months	fasting blood glucose
GMI-glucose management indicator	Three months	As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
mean glucose	Three months	As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
glucose standard deviation	Three months	As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
glucose variance coefficient	Three months	As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.
time spent at the target glucose value (Time in range)	Three months	As a continuous glucose monitoring system, Decxom G6 will be utilized and blood glucose levels of the patients will be monitored for three months.

Secondary Outcome Measures

Name	Time	Method
wound site complications	Three months	wound site complications outcome will be collected from clinical data record
rehospitalization/having surgery	Three months	rehospitalization/having surgery
pain	Three months	Visual Analog Score for pain will be assessed. Pain will be assessed between 1-10 point; 1-no pian, 10-severe pain
quality of life-EORTC QOL-C30	Three months	Also quality of life of the patients will be assessed with European Organization for the Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQQ-C30) Version 3.0. All functional scales and individual item scores are transformed to a 0-100 scale with higher values indicating a higher functioning in functional scales and an increased presence of symptoms in symptom scales.; Dear reviewer, there EORTC have 5 functional scales (physical functioning, role. functioning, emotional functioning, cognitive functioning, social functioning), global health status sub-scale, 9 symptom scales (fatigue, nause and vomiting, pain, dsypnoea, insomnia, apptite loss, constipation, diarhoea, financial difficulties). If we give each subscale, so much secondary outcomes and confused will be. Therefore we can not give each subscale as secondary outcomes.
quality of life-PAN26	Three months	Quality of life of pancreas cancer aspect will be assessed with PAN26. All functional scales and individual item scores are transformed to a 0-100 scale with higher values indicating a higher functioning in functional scales and an increased presence of symptoms in symptom scales.; Dear reviewer, The QLQ-PAN26 consists of 15 sub-scales (pancreatic pain, bloating digestive symptoms, taste, indigestion, flatulence, weight loss, weakness arms and legs, dry mouth, hepatic symptoms, altered bowel habit, body image, taubled with side-effects, future worries and planning of activities) and 2 functional scales (satisfaction with health care, and sexuality). Because there are so many subsclaes, we prefer only PAN26 quality of lie aspect.
post-operative complications	Three months	bile leakage, delayed gastric emptying, pancreatic fistula, myocardial infarct, cardiac arrythmia, pneumonia, intraabdominal abscess, bleeding outcomes as complications will be collected from clinical data record

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 Izmir, Balcova Inciralti, Turkey