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Pancreatic Anastomosis After Duodenopancreatectomy (PANGASBLUM)

Primary Purpose

Pancreatic Anastomotic Leak, Pancreatic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Blumgart Anastomosis
Pancreatogastric anastomosis.
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Anastomotic Leak

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years old.
  • Diagnosis of pancreatic and periampullary tumor pathology that requires pancreatoduodenectomy
  • Signature of informed consent by the patient or his legal representative

Exclusion Criteria:

  • Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
  • Patients in whom tumor resection is ultimately not achieved due to intraoperative evidence that the tumor is locally advanced, unresectable.
  • Patients with macroscopic residual tumor (R2).
  • High risk patients with severe pathology (ASA IV) according to the American Association of Anesthetists.

Sites / Locations

  • Hospital Clínico Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pancreatogastric anastomosis.

Blumgart Anastomosis

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Bleeding
According to the definition of the International Study Group on Pancreatic Surgery. which grades the severity of bleeding according to the clinical situation, diagnosis and need for treatment.
Gastric Emptying Delay (GED)
According to the definition of the International Study Group on Pancreatic Surgery, which establishes the existence of GED when a nasogastric tube is needed for more than 3 days or is placed from the third day of the postoperative period, as well as intolerance to an oral diet at the end of the first postoperative week.
Biliary Fistula
According to the definition of the International Study Group of Liver Surgery, which defines it as any measurable amount of fluid from a drain placed during the operation or percutaneously, with a concentration of bilirubin greater than three times the plasma value as of the third post-operative day.
Other complications.
All complications that may occur during the first 90 days of the postoperative period (including the mortality rate) should be collected and classified according to the Clavien-Dindo classification and the Comprehensive Complication Index (CCI)

Full Information

First Posted
July 3, 2020
Last Updated
August 18, 2021
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT04462354
Brief Title
Pancreatic Anastomosis After Duodenopancreatectomy
Acronym
PANGASBLUM
Official Title
Pancreatic Anastomosis After Duodenopancreatectomy: Pancreatogastrostomy Versus Blumgart Anastomosis: Prospective, Randomized and Multicentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators
Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).
Detailed Description
Background: Postoperative pancreatic fistula is currently the most frequent complications after duodenopancreatectomy. There are currently no RCT comparing two of the most frequently used method of pancreato-enteric anastomosis (invaginating pancreatogastric anastomosis versus Blumgart anastomosis) Hypothesis: in patients with resectable pancreatic and periampullary tumors, performing a Blumgart (AB) anastomosis for pancreatoenteric reconstruction after duodenopancreatectomy decreases the rate of postoperative pancreatic fistula (PPF) compared to to pancreatogastric anastomosis. Main goal: To comparatively evaluate the rate of PPF in patients with pancreatic and periampullary tumors undergoing cephalic duodenopancreatectomy after reconstruction with Blumgart anastomosis or pancreatogastric anastomosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Anastomotic Leak, Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pancreatogastric anastomosis.
Arm Type
Active Comparator
Arm Title
Blumgart Anastomosis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Blumgart Anastomosis
Intervention Description
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis
Intervention Type
Procedure
Intervention Name(s)
Pancreatogastric anastomosis.
Intervention Description
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.
Primary Outcome Measure Information:
Title
Postoperative pancreatic fistula rate (PPF)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Bleeding
Description
According to the definition of the International Study Group on Pancreatic Surgery. which grades the severity of bleeding according to the clinical situation, diagnosis and need for treatment.
Time Frame
3 months
Title
Gastric Emptying Delay (GED)
Description
According to the definition of the International Study Group on Pancreatic Surgery, which establishes the existence of GED when a nasogastric tube is needed for more than 3 days or is placed from the third day of the postoperative period, as well as intolerance to an oral diet at the end of the first postoperative week.
Time Frame
3 months
Title
Biliary Fistula
Description
According to the definition of the International Study Group of Liver Surgery, which defines it as any measurable amount of fluid from a drain placed during the operation or percutaneously, with a concentration of bilirubin greater than three times the plasma value as of the third post-operative day.
Time Frame
3 months
Title
Other complications.
Description
All complications that may occur during the first 90 days of the postoperative period (including the mortality rate) should be collected and classified according to the Clavien-Dindo classification and the Comprehensive Complication Index (CCI)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years old. Diagnosis of pancreatic and periampullary tumor pathology that requires pancreatoduodenectomy Signature of informed consent by the patient or his legal representative Exclusion Criteria: Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery. Patients in whom tumor resection is ultimately not achieved due to intraoperative evidence that the tumor is locally advanced, unresectable. Patients with macroscopic residual tumor (R2). High risk patients with severe pathology (ASA IV) according to the American Association of Anesthetists.
Facility Information:
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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Pancreatic Anastomosis After Duodenopancreatectomy

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