NCT01898780

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

4 years

First QC Date

July 9, 2013

Last Update Submit

October 3, 2019

Conditions

Patients Who Undergo Pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • The frequency of pancreatic fistula including ISGPF grade B and C

    Ninety days after operation

Secondary Outcomes (1)

  • The rates of postoperative complications

    Ninety days after operation

Study Arms (2)

horizontal mattress

EXPERIMENTAL

pancreaticojejunostomy with horizontal mattress suture

Procedure: pancreaticojejunostomy with horizontal mattress suture

interrupted suture

EXPERIMENTAL

pancreaticojejunostomy with interrupted suture

Procedure: pancreaticojejunostomy with interrupted suture

Interventions

pancreaticojejunostomy with horizontal mattress suturePROCEDURE
horizontal mattress
pancreaticojejunostomy with interrupted suturePROCEDURE
interrupted suture

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients from whom we obtained written informed consent of this study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Department of Surgery, Wakayama Medical University

Wakayama, 641-8510, Japan

Location

Related Publications (1)

  • 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.

    PMID: 29697455DERIVED

MeSH Terms

Interventions

Pancreaticojejunostomy

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Second Department of Surgery

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2017

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

JP(1)