Clinical trial NCT03030209: Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy
Official title: Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: pancreatectomy
diabetes mellitus
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 485
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing distal pancreatectomy at our single tertiary referral hospital

Brief summary: Glucose homeostasis changes after distal pancreatectomy are not well understood. This study aim to identify the incidence of and risk factors for, a change in glucose homeostasis in patients who underwent distal pancreatic resection.

Detailed description: The development of sophisticated surgical procedures, improved postoperative care, and the capacity for early diagnosis of disease, have prolonged life expectancy after pancreatic resection. For these patients, the endocrine function of the pancreas is a critical factor that influences quality of life. In this study, the investigators recruit patients who underwent distal pancreatectomy in Peking Union Medical College Hospital within the last 10 years. Demographic characteristics, operative parameters and short-term postoperative outcomes were collected in a prospective database maintained by the Pancreatic Surgical Centre, Peking Union Medical College Hospital. These patients are followed up regularly by outpatient visiting or telephone for long-term outcomes. The primary outcome of this study is new-onset diabetes mellitus; second outcomes include impaired fasting glucose, impaired glucose tolerance, exocrine insufficiency and disease recurrence. This study aim to determine the cumulative rates of endocrine insufficiency, and identify risk factors for DM development in a large cohort of patients undergoing distal pancreatectomy.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing distal pancreatectomy

Exclusion Criteria:

* Patients undergoing pancreaticoduodenectomy, middle pancreatectomy and enucleation
* Patients with preoperative DM
* Patients with functioning insulinoma and multiple endocrine neoplasia type 1

Primary outcomes:
measure: Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
measure: Number of participants with new-onset prediabetes as defined by American Diabetes Association
timeFrame: Through study completion, an average of 3 year
measure: Number of participants with new-onset exocrine insufficiency
timeFrame: Through study completion, an average of 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Study officials:
affiliation: Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
name: Menghua Dai, M.D.
role: STUDY_CHAIR
References:
citation: Kwon JH, Kim SC, Shim IK, Song KB, Lee JH, Hwang DW, Park KM, Lee YJ. Factors Affecting the Development of Diabetes Mellitus After Pancreatic Resection. Pancreas. 2015 Nov;44(8):1296-303. doi: 10.1097/MPA.0000000000000404.
citation: Shirakawa S, Matsumoto I, Toyama H, Shinzeki M, Ajiki T, Fukumoto T, Ku Y. Pancreatic volumetric assessment as a predictor of new-onset diabetes following distal pancreatectomy. J Gastrointest Surg. 2012 Dec;16(12):2212-9. doi: 10.1007/s11605-012-2039-7. Epub 2012 Sep 28.
citation: King J, Kazanjian K, Matsumoto J, Reber HA, Yeh MW, Hines OJ, Eibl G. Distal pancreatectomy: incidence of postoperative diabetes. J Gastrointest Surg. 2008 Sep;12(9):1548-53. doi: 10.1007/s11605-008-0560-5. Epub 2008 Jun 10.
citation: You DD, Choi SH, Choi DW, Heo JS, Ho CY, Kim WS. Long-term effects of pancreaticoduodenectomy on glucose metabolism. ANZ J Surg. 2012 Jun;82(6):447-51. doi: 10.1111/j.1445-2197.2012.06080.x. Epub 2012 May 9.
citation: Dai M, Xing C, Shi N, Wang S, Wu G, Liao Q, Zhang T, Chen G, Wu W, Guo J, Liu Z. Risk factors for new-onset diabetes mellitus after distal pancreatectomy. BMJ Open Diabetes Res Care. 2020 Oct;8(2):e001778. doi: 10.1136/bmjdrc-2020-001778.