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Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01898780
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2013
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hiroki Yamaue, Wakayama Medical University

Tracking Information
First Submitted Date  ICMJE July 9, 2013
First Posted Date  ICMJE July 12, 2013
Last Update Posted Date October 7, 2019
Study Start Date  ICMJE June 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
The frequency of pancreatic fistula including ISGPF grade B and C [ Time Frame: Ninety days after operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
The rates of postoperative complications [ Time Frame: Ninety days after operation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy
Official Title  ICMJE Not Provided
Brief Summary The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patients Who Undergo Pancreatoduodenectomy
Intervention  ICMJE
  • Procedure: pancreaticojejunostomy with horizontal mattress suture
  • Procedure: pancreaticojejunostomy with interrupted suture
Study Arms  ICMJE
  • Experimental: horizontal mattress
    pancreaticojejunostomy with horizontal mattress suture
    Intervention: Procedure: pancreaticojejunostomy with horizontal mattress suture
  • Experimental: interrupted suture
    pancreaticojejunostomy with interrupted suture
    Intervention: Procedure: pancreaticojejunostomy with interrupted suture
Publications * Hirono S, Kawai M, Okada KI, Miyazawa M, Kitahata Y, Hayami S, Ueno M, Yamaue H. Modified Blumgart Mattress Suture Versus Conventional Interrupted Suture in Pancreaticojejunostomy During Pancreaticoduodenectomy: Randomized Controlled Trial. Ann Surg. 2019 Feb;269(2):243-251. doi: 10.1097/SLA.0000000000002802.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 11, 2013)
190
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients from whom we obtained written informed consent of this study

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
  • Patients who are considered as inappropriate by attending physician
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01898780
Other Study ID Numbers  ICMJE HOMING
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hiroki Yamaue, Wakayama Medical University
Study Sponsor  ICMJE Wakayama Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wakayama Medical University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP