Trials Sponsors Conditions Drugs Pricing

Conditions

Pancreatic Anastomotic Leak Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

Postoperative pancreatic fistula rate (PPF)
The post-operative pancreatic fistula (PPF) rate will be measured using the definition of the International Study Group of Pancreatic Fistula (ISGPF) : any measurable amount of fluid from a drain placed during the operation or percutaneously, with an amylase concentration greater than three times the plasma value.
3 months

Secondary Outcomes (4)

Bleeding
3 months
Gastric Emptying Delay (GED)
3 months
Biliary Fistula
3 months
Other complications.
3 months

Study Arms (2)

Pancreatogastric anastomosis.

ACTIVE COMPARATOR

Procedure: Pancreatogastric anastomosis.

Blumgart Anastomosis

EXPERIMENTAL

Procedure: Blumgart Anastomosis

Interventions

Blumgart AnastomosisProcedure

Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis

Blumgart Anastomosis

Pancreatogastric anastomosis.Procedure

Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.

Pancreatogastric anastomosis.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients over 18 years old.
Diagnosis of pancreatic and periampullary tumor pathology that requires pancreatoduodenectomy

Sponsors & Collaborators

Instituto de Salud Carlos III
Governmentcollaborator
Fundación para la Investigación del Hospital Clínico de Valencia
Otherlead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Enrollment

216 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 8, 2020

Study Start

June 4, 2020

Actual (reported)

Pancreatic Anastomosis After Duodenopancreatectomy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Pancreatogastric anastomosis.

Blumgart Anastomosis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

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)

Secondary Outcomes (4)

Study Arms (2)

Pancreatogastric anastomosis.

Blumgart Anastomosis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations