Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy

NCT ID: NCT01898780

Last Updated: 2019-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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

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Conditions

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Patients Who Undergo Pancreatoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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horizontal mattress

pancreaticojejunostomy with horizontal mattress suture

Group Type EXPERIMENTAL

pancreaticojejunostomy with horizontal mattress suture

Intervention Type PROCEDURE

interrupted suture

pancreaticojejunostomy with interrupted suture

Group Type EXPERIMENTAL

pancreaticojejunostomy with interrupted suture

Intervention Type PROCEDURE

Interventions

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pancreaticojejunostomy with horizontal mattress suture

Intervention Type PROCEDURE

pancreaticojejunostomy with interrupted suture

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wakayama Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hiroki Yamaue

Second Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Second Department of Surgery, Wakayama Medical University

Wakayama, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 29697455 (View on PubMed)

Other Identifiers

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HOMING

Identifier Type: -

Identifier Source: org_study_id

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