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NCT01984216 Clinical Trial

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

Pancreatoduodenectomy Clinical Trial

Official title:
Billroth II Versus Roux-en-Y for the Gastrojejunostomy Reconstruction in the Pancreatoduodenectomy: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01984216
Other study ID # CIRUGIA-CHN
Secondary ID 2013-000693-30
Status Completed
Phase N/A
First received November 7, 2013
Last updated August 26, 2016
Start date November 2013
Est. completion date August 2016

Study information
Verified date August 2016
Source Fundacion Miguel Servet
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Procedure:
• Roux-en-Y for the gastrojejunostomy reconstruction

• Billroth II for the gastrojejunostomy reconstruction

Locations
Country Name City State
Spain Complejo Hospitalario de Navarra Pamplona Navarre

Sponsors (1)
Lead Sponsor Collaborator
Fundacion Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of delayed gastric emptying (DGE) 30 day after surgery No
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