Pancreatic Anastomosis After Duodenopancreatectomy (PANGASBLUM)

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Completed

Conditions: Pancreatic Anastomotic Leak; Pancreatic Neoplasms

Treatments: Procedure: Pancreatogastric anastomosis.; Procedure: Blumgart Anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04462354

PANGASBLUM

Details and patient eligibility

About

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

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Pancreatogastric anastomosis.

Active Comparator group

Treatment:

Procedure: Pancreatogastric anastomosis.

Blumgart Anastomosis

Experimental group

Treatment:

Procedure: Blumgart Anastomosis