NCT04633382

Brief 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".

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 12, 2020

Last Update Submit

November 17, 2020

Conditions

Biliary StrictureCholangiocarcinomaCholangitis; Choledocholithiasis

Keywords

Fast track, Enhanced recovery after surgery, biliary surgery

Outcome Measures

Primary Outcomes (1)

  • Reduction of bed-days

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

    1 week

Study Arms (2)

Conducting research of enhanced recovery after surgery

EXPERIMENTAL

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

Conducting research of traditional recovery after surgery

PLACEBO COMPARATOR

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

Enhanced recovery after biliary tract surgeryCOMBINATION_PRODUCT

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

Conducting research of enhanced recovery after surgeryConducting research of traditional recovery after surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Scale ASA\> III (severe concomitant cardiovascular pathology).
  • Palliative reconstructive surgery.
  • Previously performed operations on the bile ducts (up to 1 month).
  • Cachexia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CholangiocarcinomaCholangitisCholedocholithiasis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCommon Bile Duct DiseasesCholelithiasis

Central Study Contacts

Yury N Arlouski, MD

CONTACT

+375296374668orl_doc@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, PhD

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

January 1, 2021

Primary Completion

January 31, 2021

Study Completion

January 1, 2022

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share