Pancreatic Anastomosis After Duodenopancreatectomy

Pancreatic Neoplasms Clinical Trial

— PANGASBLUM  

Official title:

Pancreatic Anastomosis After Duodenopancreatectomy: Pancreatogastrostomy Versus Blumgart Anastomosis: Prospective, Randomized and Multicentric Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04462354
• Other study ID #: PANGASBLUM
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 4, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Pancreatic Anastomotic Leak
• Pancreatic Neoplasms

Intervention

Procedure:
• Blumgart Anastomosis
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis
• Pancreatogastric anastomosis.
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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)	3 months