UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of pancreatic exocrine function after pancreaticoduodenectomy
Acronym	Prospective study of pancreatic exocrine function after pancreaticoduodenectomy
Scientific Title	Prospective study of pancreatic exocrine function after pancreaticoduodenectomy
Scientific Title:Acronym	Prospective study of pancreatic exocrine function after pancreaticoduodenectomy
Region	Japan

Condition
Condition	Periampullary tumor
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the difference of pancreatico-enteric anastomosis in long-term pancreatic exocrine function after pancreaticoduodenectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Incidence of pancreatic exocrine inefficiency one year after surgery
Key secondary outcomes	The Incidence of pancreatic exocrine inefficiency three months and two year after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Duct-to-mucosa pancreatico-gastrostomy for pancreatico-enterostomy
Interventions/Control_2	Duct-to-mucosa pancreatico-jejunosotmy for pancreatico-enterostomy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	On the diagnosis of periampullary malignancy, benign tumor or inflammatory disease, the patient is going to undergo pancreaticoduodenectomy with duodeno-jejunostomy
Key exclusion criteria	1.Patients with acute ischemic heart disease 2.Patients with liver cirrhosis or active hepatitis 3. Patients with interstitial pneumonia or fibroid lung who require oxygen administration 4. Patients with chronic renal failure requiring dialysis 5. Patients with other malignant disease 6. Patients who require concomitant resection of other organ 7. Patients who are diagnosed to be ineligible by the investigator.
Target sample size	74

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yoshiaki Murakami
Organization	Hiroshima University Hospital
Division name	Gastrointestinal Surgery
Zip code
Address	1-2-3Kasumi, Minamiku, Hiroshima
TEL	082-257-5216
Email

Public contact
1st name of contact person	1st name Middle name Last name Kenichiro Uemura
Organization	Hiroshima University Hospital
Division name	Gastrointestinal Surgery
Zip code
Address	1-2-3Kasumi, Minamiku, Hiroshima
TEL	082-257-5216
Homepage URL
Email

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Wakayama Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	広島大学病院（広島県）、和歌山県立医科大学病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 16 Day
Date of IRB	2011 Year 06 Month 16 Day
Anticipated trial start date	2011 Year 06 Month 16 Day
Last follow-up date	2017 Year 06 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 06 Month 11 Day
Last modified on	2019 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006688