NCT01984216

Completed

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

Fundacion Miguel Servet Source

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Other study identifiers

Sponsor study identifier

CIRUGIA-CHN

Secondary identifiers

2013-000693-30

EUDRACT_NUMBER

Study Type

interventional

Actual enrollment (reported)

64

Locations

1 country

Sites

1

Timeline

Study Start

November 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2016

Actual (reported)

Study Completion

August 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 64 participants
Study completion date: August 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 7, 2013
Actual (reported)
First Posted
November 14, 2013
Actual (reported)
Primary Completion
August 2016
Actual (reported)
Study Completion
August 2016
Actual (reported)

Last Updated: August 29, 2016
Status Verified: August 2016
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Fundacion Miguel Servet
Otherlead

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

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

Enrollment

64 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

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NCT06322680

Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy

Not ApplicableRecruiting

NCT03767959

Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

Not ApplicableUnknown

NCT04171440

Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy

Not ApplicableCompleted

NCT02127021

The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

Phase 4Completed

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.

Primary Completion

August 2016

Actual (reported)

Study Completion

August 2016

Actual (reported)

Last Updated

August 29, 2016

Record last verified: 2016-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01984216
Data provider: ClinicalTrials.gov
Source updated: 2016-08-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:56 UTC

Locations

ES(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Roux-en-Y

Billroth II

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Roux-en-Y

Billroth II

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations