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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005463
Receipt No. R000006481
Scientific Title Effect of Stapled vs. Hand-sewn duodenal reconstruction on delayed gastric emptying during pancreaticoduodenectomy: a dual-center randomized controlled trial
Date of disclosure of the study information 2011/04/19
Last modified on 2013/08/08

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Basic information
Public title Effect of Stapled vs. Hand-sewn duodenal reconstruction on delayed gastric emptying during pancreaticoduodenectomy: a dual-center randomized controlled trial
Acronym SH-Trial
Scientific Title Effect of Stapled vs. Hand-sewn duodenal reconstruction on delayed gastric emptying during pancreaticoduodenectomy: a dual-center randomized controlled trial
Scientific Title:Acronym SH-Trial
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the incidence of delayed gastric emptying in patients undergoing pylorus-preserving pancreaticoduodenectomy between stapled and hand-sewn duodeno-jejunostomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of delayed gastric emptying defined by ISGPS
Key secondary outcomes reconstruction time, findings on upper gastrography on day 4-7, incidence of pancreatic fistula, incidence of complication, hospital stay, rate of body weight loss

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention is stapled anastomosis using circular stapler on duodeno-jejunostomy after pancreaticoduodenectomy
Interventions/Control_2 Control arm is hand-sewn anastomosis on duodeno-jejunostomy after pancreaticoduodenectomy
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria On the diagnosis of periampullary malignancy, benign tumor or inflammatory disease, the patient is going to undergo pylorus-preserving pancreaticoduodenectomy with duodeno-jejunostomy
Key exclusion criteria 1) patients undergoing total pancreatectomy
2) patients who has undergone gastric bypass or gastrectomy
3) patients undergoing pancreaticoduodenectomy plus hemihepatectomy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Sakamoto
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Divison, Artificial organ and Liver transplantation Division, Department of Surgery,
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoji Kishi
Organization National Cancer Center Hospital
Division name Hepatobiliary and Pancreatic Surgery Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email yokishi@ncc.go.jp

Sponsor
Institute "Objective evaluation & study of effect of Hepatobiliary and Pancreatic Surgery Technique, and reconstruction of minimally invasive surgery for HBP malignancy" (Shimada Group"
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research from the Ministry of Health and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 国立がん研究センター中央病院、癌研究会附属有明病院

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 19 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 03 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 07 Month 01 Day
Date of closure to data entry
2013 Year 07 Month 01 Day
Date trial data considered complete
2013 Year 08 Month 01 Day
Date analysis concluded
2013 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 18 Day
Last modified on
2013 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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