Clinical trial NCT06774170: Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery
Official title: Effect of Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pancreas Cancer
Diabetes
Keywords: pancreas cancer
pancreaticoduodenectomy
continuous glucose monitoring
type 3c diabetes mellitus
data mining
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-01-14
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has a single-center, randomized, controlled, single-blind design. The study sample will include 40 patients (20 intervention group, 20 control group) with PD. The allocation ratio will be 1:1.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: Three months
measure: fasting blood glucose
timeFrame: Three months
measure: mean glucose
timeFrame: Three months
measure: glucose standard deviation
timeFrame: Three months
measure: glucose variance coefficient
timeFrame: Three months
measure: GMI-glucose management indicator
timeFrame: Three months
measure: time spent at the target glucose value (Time in range)
timeFrame: Three months
Secondary outcomes:
measure: rehospitalization/having surgery
timeFrame: Three months
measure: wound site complications
timeFrame: Three months
measure: post-operative complications
timeFrame: Three months
measure: pain
timeFrame: Three months
measure: quality of life-EORTC QOL-C30
timeFrame: Three months
measure: quality of life-PAN26
timeFrame: Three months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
state: Balcova Inciralti
Study officials:
References: