Billroth II Versus Roux-en-Y for the Gastrojejunostomy in... | NCT01984216

Studies
Billroth II Versus Roux-en-Y for the Gastrojejunostomy in the Pancreatoduodenectomy

NCT01984216

Sponsor

Fundacion Miguel Servet

Status

Completed

Last Update Posted

Aug 29, 2016Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Pancreatoduodenectomy

Interventions

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

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-000693-30	EudraCT Number

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Nov 7, 2013

First Submission Date that Met QC Criteria

Nov 7, 2013

First Posted Date

Nov 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2016

Last Update Posted Date

Aug 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Roux-en-Y for the gastrojejunostomy reconstruction	Procedure		Roux-en-Y
Billroth II for the gastrojejunostomy reconstruction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of delayed gastric emptying (DGE)		30 day after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francisco Javier Herrera, MD	Complejo Hospitalario de Navarra	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Complejo Hospitalario de Navarra		Pamplona	Navarre	31008	Spain

References Module

Citations

Not provided

ID	Term
D000713	Anastomosis, Roux-en-Y
D005763	Gastroenterostomy

ID	Term
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D013505	Digestive System Surgical Procedures