Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management

NCT04380506 | Unknown

• 1 other identifier: 24/20 PAR ComEt CBM
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic fistula (PF) represents the Achille's heel of pancreatic surgery and is the main cause of postoperative morbidity since it can determine the onset of others complications such as abdominal abscesses, surgical wound infections, sepsis and bleeding, that can sometimes be fatal. During a previous study conducted at the University Campus Bio-Medico of Rome, Department of General Surgery there were identified cut-offs of amylase levels on the abdominal drainage fluid dosed in I postoperative day (POD1) and III postoperative day (POD3) which can significantly predict PF and in particular clinically relevant fistulas as well as abdominal collections and biliary fistulas, if related to some specific findings of the abdominal CT routine performed in POD3. The aim of this research project is to validate the cut-offs of the amylase levels on drainage fluid identified during the previous research in order to identify patients at risk of clinically relevant PF and to validate the use of abdomen CT without contrast in POD3 in patients with increased risk of biliary fistula.

Conditions

Pancreas Cancer; Pancreatic Fistula

Keywords

Surgical Drain Managment; Pancreatic Fistula; Postoperative Complication; Amylase Drain level

Outcome Measures

Primary Outcomes (2)

• Validate the cut-offs of the amylase levels on drainage fluid identified during the previous research in order to identify patients at risk of clinically relevant FP

  The management of drainages and the execution of the abdomen CT scan in Postoperative day 3 will be managed on the basis of the outcome of the assay of amylase levels performed on fluid collected by surgical drains. This evaluation will be performed each day in the first three postoperative days or until drains removal.

  From postoperative day 1 to postoperative day 90

• Validate the ability of the diameter (in cm) of abdominal collection detected during the contrast-free abdomen CT in POD3 to predict risk of biliary fistula

  The relation between abdominal collections (measured in centimeters) detected with abdomen CT scan and the risk of develop a biliary fistula.

  From postoperative day 1 to postoperative day 90

Study Arms (1)

Drain removal

EXPERIMENTAL

Patients that fulfill criteria for surgical drains removal

Procedure: Surgical Drains Management

Interventions

Surgical Drains Management PROCEDURE

The Role of Amylase Drain Level in the Management of Surgical Drains after Pancreratoduodenectomy

Drain removal

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years old
• elective open or laparoscopic PD

You may not qualify if:

• age \<to 18 years;
• Emergency surgery;
• other pancreatic resections (not PD).

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

University Hospital Campus Bio-Medico of Rome

Roma, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Fistula; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Damiano Caputo, MD

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Rossi

CONTACT

0039225411257; a.rossi@unicampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 8, 2020
• Study Start: March 15, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)