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NCT Number: NCT06774170

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

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.

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Key information

Conditions

Pancreas Cancer Diabetes Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, Balcova Inciralti, 35340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

structured follow-up intervention

Behavioral

The intervention has been created in light of the studies including type 1 and type 2 diabetes patients and experiences of the project team with patients after PD. Theoretical background of the intervention is based on the interventions developed for glucose management in type 1 and type 2 diabetes patients and the effect of the intervention will be evaluated by using the "plan-do-check-act" model.

Primary outcomes

  1. HbA1c

    Time frame: Three months

    HbA1c

  2. fasting blood glucose

    Time frame: Three months

    fasting blood glucose

  3. mean glucose

    Time frame: 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.

  4. glucose standard deviation

    Time frame: 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.

  5. glucose variance coefficient

    Time frame: 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.

  6. GMI-glucose management indicator

    Time frame: 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.

  7. time spent at the target glucose value (Time in range)

    Time frame: 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 outcomes

  1. rehospitalization/having surgery

    Time frame: Three months

    rehospitalization/having surgery

  2. wound site complications

    Time frame: Three months

    wound site complications outcome will be collected from clinical data record

  3. post-operative complications

    Time frame: 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

  4. pain

    Time frame: Three months

    Visual Analog Score for pain will be assessed. Pain will be assessed between 1-10 point; 1-no pian, 10-severe pain

  5. quality of life-EORTC QOL-C30

    Time frame: 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.

  6. quality of life-PAN26

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Effect of Structured Follow-up Intervention on Glucose Status After Pancreatic Cancer Surgery: a Randomized Controlled Trial

Acronym: FiGluR

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jan 23, 2025

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

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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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