ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Cholangiocarcinoma Clinical Trial

Official title:

JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04633382
• Other study ID #: Biliary interventional
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2020
• Source: Vitebsk State Medical University
• Contact: Yury N Arlouski, MD
• Phone: +375296374668
• Email: orl_doc[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to improve the immediate results after reconstructive and restorative operations on the biliary tract by substantiating the management of the perioperative period on the principles of "enhanced recovery after surgery".

Description:

A prospective randomized study on the effect of fast-track surgery on the immediate postoperative results after various reconstructive and restorative operations on the bile ducts. In the Department of Surgical Hepatology and Transplantation, a prospective randomized study will include patients (about 50) with planned reconstructive and restorative operations on the bile ducts for malignant and benign diseases of the bile ducts.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients with malignant diseases of the biliary tract (cholangiocarcinoma):

1.1. tumor resectability 1.2. absence:

• distant metastases
• carcinomatosis
• perforation of the tumor and peritonitis
• sprouting into adjacent organs and tissues (locally advanced cancer)
• total adhesion process in the abdominal cavity (after previous operations). 1.3. Planned reconstructive surgery on the biliary tract.

2. Patients with benign biliary tract pathology. 2.1. Planned reconstructive or

restorative surgery on the biliary tract for the following diseases:

• choledocholithiasis
• Mirizzi syndrome
• cysts of the common bile duct
• strictures of the common bile duct
• injuries to the bile ducts
• adenoma and stricture of the OBD

Exclusion Criteria:

1. Scale ASA> III (severe concomitant cardiovascular pathology).

2. Palliative reconstructive surgery.

3. Previously performed operations on the bile ducts (up to 1 month).

4. Cachexia.

Related Conditions & MeSH terms

• Biliary Stricture
• Cholangiocarcinoma
• Cholangitis
• Cholangitis; Choledocholithiasis
• Choledocholithiasis

Intervention

Combination Product:
• Enhanced recovery after biliary tract surgery
Patients with malignant and benign diseases of the bile ducts, who have formed various types of anastomosis in two options for managing the postoperative period: traditional and based on the principles of enhanced recovery after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vitebsk State Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of bed-days	Improvement of basic health indicators, absence of complications, reduction of bed days	1 week