Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

NCT ID: NCT03030209

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

485 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-01

Study Completion Date

2016-02-13

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Distal Pancreatectomy

Patients undergoing distal pancreatectomy

Distal pancreatectomy

Intervention Type PROCEDURE

Distal pancreatectomy with or without splenectomy using minimal invasive or open approach

Interventions

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Distal pancreatectomy

Distal pancreatectomy with or without splenectomy using minimal invasive or open approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Menghua Dai, M.D.

Role: STUDY_CHAIR

Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Locations

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Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 26390413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23054900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18543045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22571457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33122295 (View on PubMed)

Other Identifiers

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PUMCH-GS03

Identifier Type: -

Identifier Source: org_study_id

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