CClinicalTrials.gg
Status unknownNCT04633382Updated Nov 19, 2020

ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

An interventional study of Enhanced recovery after biliary tract surgery in Biliary Stricture, Cholangiocarcinoma and Cholangitis; Choledocholithiasis, sponsored by Vitebsk State Medical University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by Vitebsk State Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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".

Read the detailed 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.

02

Conditions studied

  • Biliary Stricture
  • Cholangiocarcinoma
  • Cholangitis; Choledocholithiasis

Keywords

  • Fast track, Enhanced recovery after surgery, biliary surgery
03

In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Vitebsk State Medical University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Conducting research of enhanced recovery after surgery

    1. Informing the patient about the course of the operation and the postoperative period. Psychological preparation. 2. Refusal from complete starvation. Carbohydrate drink 2 hours before surgery. 3. Refusal of cleansing enemas. 4. Refusal of premedication. NSAIDs 30 minutes before surgery 5. Prevention of thromboembolic complications 6. Multimodal analgesia: epidural catheter, paracetamol. 7. Minimally invasive access. 8. Prevention of hypothermia 9. Targeted infusion therapy. 10. Failure or limited time use of drainages: gastric, intra-abdominal, bile duct drainage. 11. Early activation of the patient. 12. Early enteral nutrition. 13. Prevention of nausea and vomiting.

    Combination Product: Enhanced recovery after biliary tract surgery

  • Placebo comparator
    Conducting research of traditional recovery after surgery

    1. Informing the patient about the course of the operation and the postoperative period. Psychological preparation. 2. Fasting for 2 days 3. Use of cleansing enemas. Bowel preparation 4. Premedication 5. Prevention of thromboembolic complications 6. Without multimodal analgesia 7. Traditional access. 8. Prevention of hypothermia 9. Targeted infusion therapy. 10. Use of drains: gastric, intra-abdominal, bile duct drainage. 11. Activation of patients within 2 days. 12. Enteral nutrition after 2 days after surgery. 13. Without the use of metoclopramide

    Combination Product: Enhanced recovery after biliary tract surgery

Interventions

  • Combination productEnhanced 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

06

What researchers measure

Primary outcomes

  1. Reduction of bed-days

    Improvement of basic health indicators, absence of complications, reduction of bed days

    Time frame: 1 week

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04633382
Lead sponsor
Vitebsk State Medical University
Responsible party
Yury Arlouski (Associate professor, MD, PhD, Vitebsk State Medical University) — Principal investigator
First posted
Nov 18, 2020
Start date
Jan 1, 2021 (estimated)
Primary completion
Jan 31, 2021 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Nov 19, 2020

Study contacts

Yury N Arlouski, MD
Contact
orl_doc@hotmail.com
+375296374668

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion