UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Horizontal matress suture vs interrupted suture in surgical techniques of pancreaticojejunostomy -randomized clinical trial-
Title of the study (Brief title)	Horizontal Matress vs interrupted suture in surgical techniques of pancreaticojejunostomy
Region	Japan

Condition
Condition	Patients who undergo pancreatoduodenectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal matress suture are lower than in interrupted suture during pancreaticojejunostomy by RCT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of pancreatic fistula including ISGPF grade B and C
Key secondary outcomes	Perioperative factors, the rates of postoperative complications, the degree of atrophy in the remnant pancreas, postoperative endocrine and exocrine pancreatic function, frequency of pancreatic fistula including ISGPF grade A, B, and C, time during pancreticojejunostomy, cost of suture required for pancreaticojejunostomy

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	horizontal matress suture in pancreaticojejunostomy n=95
Interventions/Control_2	interrupted suture in pancreaticojejunostomy n=95
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients from whom we obtained written informed consent of this study.
Key exclusion criteria	Patients with severe ischemic cardiac disease, patients with severe liver damage, patients requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis, patients requiring dialysis treatment due to chronic renal failure, or patients who are considered as inappropriate by attendig physician
Target sample size	224

Research contact person
Name of lead principal investigator	Seiko Hirono
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama 641-8510, Japan
TEL	+81-73-441-0613
Email	seiko-h@wakayama-med.ac.jp

Public contact
Name of contact person	Seiko Hirono
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama 641-8510, Japan
TEL	+81-73-441-0613
Homepage URL
Email	seiko-h@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 17 Day
Anticipated trial start date	2013 Year 06 Month 20 Day
Last follow-up date	2017 Year 08 Month 31 Day
Date of closure to data entry	2017 Year 10 Month 31 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 04 Month 30 Day

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

Management information
Registered date	2014 Year 12 Month 14 Day
Last modified on	2018 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012884