NCT01984216

Brief Summary

The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

November 7, 2013

Last Update Submit

August 26, 2016

Conditions

Pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of delayed gastric emptying (DGE)

    30 day after surgery

Study Arms (2)

Roux-en-Y

EXPERIMENTAL

Roux-en-Y for the gastrojejunostomy reconstruction

Procedure: Roux-en-Y for the gastrojejunostomy reconstruction

Billroth II

ACTIVE COMPARATOR

Billroth II for the gastrojejunostomy reconstruction

Procedure: Billroth II for the gastrojejunostomy reconstruction

Interventions

Roux-en-Y for the gastrojejunostomy reconstructionPROCEDURE
Roux-en-Y
Billroth II for the gastrojejunostomy reconstructionPROCEDURE
Billroth II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive series of patients undergoing pancreaticoduodenectomy (PD).
  • Given informed consent.

You may not qualify if:

  • Inability to perform pancreatogastrostomy.
  • Resection of other organs, except the superior mesenteric-portal vein.
  • Previous gastric surgery.
  • Preoperative gastric or duodenal obstruction.
  • Previous complex abdominal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Links

MeSH Terms

Interventions

Anastomosis, Roux-en-YGastroenterostomy

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Francisco Javier Herrera, MD

    Complejo Hospitalario de Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

November 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

ES(1)