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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

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.

Condition or disease Intervention/treatment Phase
Patients Who Undergo Pancreatoduodenectomy Procedure: pancreaticojejunostomy with horizontal mattress suture Procedure: pancreaticojejunostomy with interrupted suture Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2013
Actual Primary Completion Date : June 2017

Arm Intervention/treatment
Experimental: horizontal mattress
pancreaticojejunostomy with horizontal mattress suture
Procedure: pancreaticojejunostomy with horizontal mattress suture
Experimental: interrupted suture
pancreaticojejunostomy with interrupted suture
Procedure: pancreaticojejunostomy with interrupted suture



Primary Outcome Measures :
  1. The frequency of pancreatic fistula including ISGPF grade B and C [ Time Frame: Ninety days after operation ]

Secondary Outcome Measures :
  1. The rates of postoperative complications [ Time Frame: Ninety days after operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898780


Locations
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Japan
Second Department of Surgery, Wakayama Medical University
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hiroki Yamaue, Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT01898780    
Other Study ID Numbers: HOMING
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019