UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of effect of Braun enteroenterostomy on the postoperative outcomes after pylorus-preserving pancreatoduodenectomy : a randomized controlled trial
Title of the study (Brief title)	Effect of Braun enteroenterostomy on PPPD
Region	Japan

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

Objectives
Narrative objectives1	To evaluate effects of Braun enteroenterostomy added to pylorus-preserving pancreatoduodenectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of delayed gastric emptying
Key secondary outcomes	Incidence of anastomotic site ulceration, operation time, postoperative hospital stay, symptoms

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	With Braun enteroenterostomy
Interventions/Control_2	Without Braun enteroenterostomy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) The patients aged 20 years and older (2) The patients who are scheduled for elective surgery (3) The patients who will undergo PPPD under general anesthesia (4) The patients who have PS 2 and under (5) The patients who have ASA-PS 3 and under (6) The patients who fully agree to this trial
Key exclusion criteria	(1) The patients who have history of preoperative chemotherapy (2) The patients who are unable to be given general anesthesia (3) The patients who have history of pancreatic resection (4) The patients who are planned to undergo PPPD with laparoscopy (5) The patients who need conversion to PD (6) The patients who have unresectable cancer
Target sample size	120

Research contact person
Name of lead principal investigator	Nakamura Masafumi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Oncology
Address	3-1-1 Maidashi Higashi-ku Fukuoka Japan
TEL	092-642-5440
Email	mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person	Takaaki Fujimoto
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Oncology
Address	3-1-1 Maidashi Higashi-ku Fukuoka Japan
TEL	092-642-5440
Homepage URL
Email	takaakif@surg1.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Surgery and Oncology; Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology Research fund
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 30 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 01 Day
Last modified on	2017 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018393