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NCT Number: NCT04462354

Pancreatic Anastomosis After Duodenopancreatectomy

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

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Key information

Conditions

Pancreatic Anastomotic Leak Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blumgart Anastomosis

Procedure

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

Pancreatogastric anastomosis.

Procedure

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

Primary outcomes

  1. Postoperative pancreatic fistula rate (PPF)

    Time frame: 3 months

    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 outcomes

  1. Bleeding

    Time frame: 3 months

    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.

  2. Gastric Emptying Delay (GED)

    Time frame: 3 months

    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. Biliary Fistula

    Time frame: 3 months

    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.

  4. Other complications.

    Time frame: 3 months

    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)

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: PANGASBLUM

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2020
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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