ClinicalTrials.gg
Status unknownNCT01898780Updated Oct 7, 2019

Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy

A Phase 3 interventional study of pancreaticojejunostomy with horizontal mattress suture and pancreaticojejunostomy with interrupted suture in Patients Who Undergo Pancreatoduodenectomy, sponsored by Wakayama Medical University. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-10-07.

Sponsored by Wakayama Medical University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Enrolling by invitation — may be out of date.

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Phase
Phase 3
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients Who Undergo Pancreatoduodenectomy
03

In context

Lead sponsor

Wakayama Medical University is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients from whom we obtained written of this study

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
190 participants (estimated)

Study arms

  • 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

Interventions

  • Procedurepancreaticojejunostomy with horizontal mattress suture
  • Procedurepancreaticojejunostomy with interrupted suture
06

What researchers measure

Primary outcomes

  1. The frequency of pancreatic fistula including ISGPF grade B and C

    Time frame: Ninety days after operation

Secondary outcomes

  1. The rates of postoperative complications

    Time frame: Ninety days after operation

07

Study locations

1 site
  • Second Department of Surgery, Wakayama Medical University
    Wakayama, 641-8510, Japan
08

References and documents

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. PubMed 29697455 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013 and a primary completion of Jun 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2013
First posted
Jul 12, 2013
Start
Jun 2013
Primary completionActual
Jun 2017
Last update
Oct 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01898780
Lead sponsor
Wakayama Medical University
Responsible party
Hiroki Yamaue (Second Department of Surgery, Wakayama Medical University) — Principal investigator
First posted
Jul 12, 2013
Start date
Jun 2013
Primary completion
Jun 2017
Last update
Oct 7, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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