Biliary StrictureNCT04633382
ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY
A study testing Enhanced recovery after biliary tract surgery in people with Biliary Stricture and Cholangiocarcinoma, run by Vitebsk State Medical University.
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". Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Stricture, Cholangiocarcinoma, Cholangitis; Choledocholithiasis
- What is being tested?
- Enhanced recovery after biliary tract surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- Scale ASA> III (severe concomitant cardiovascular pathology).
- Palliative reconstructive surgery.
- Previously performed operations on the bile ducts (up to 1 month).
- Cachexia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY
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.
- Being tested
- Enhanced recovery after biliary tract surgery
- Keywords
- Fast track, Enhanced recovery after surgery, biliary surgery
- Medical subject headings
- Cholangiocarcinoma, Cholangitis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Combination Product: Enhanced recovery after biliary tract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of bed-days
Improvement of basic health indicators, absence of complications, reduction of bed days
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitebsk State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yury Arlouski, Vitebsk State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633382
- Sponsor's protocol ID
- Biliary interventional
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY
- ClinicalTrials.gov ID
- NCT04633382
- Acronym / sponsor ID
- Biliary interventional
- Keywords
- Fast track, Enhanced recovery after surgery, biliary surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vitebsk State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conducting research of enhanced recovery after surgery | Experimental | Combination Product: Enhanced recovery after biliary tract surgery1. 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. |
| Conducting research of traditional recovery after surgery | Placebo comparator | Combination Product: Enhanced recovery after biliary tract surgery1. 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with malignant diseases of the biliary tract (cholangiocarcinoma):
- Patients with benign biliary tract pathology. 2.1. Planned reconstructive or restorative surgery on the biliary tract for the following diseases:
Key exclusion criteria (4 listed)
- Scale ASA> III (severe concomitant cardiovascular pathology).
- Palliative reconstructive surgery.
- Previously performed operations on the bile ducts (up to 1 month).
- Cachexia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after biliary tract surgeryPatients 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 | Combination product | Conducting research of enhanced recovery after surgery, Conducting research of traditional recovery after surgery |
Primary outcome
Reduction of bed-days
Time frame: 1 week
Improvement of basic health indicators, absence of complications, reduction of bed days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery after biliary tract surgery in people with Biliary Stricture and Cholangiocarcinoma, run by Vitebsk State Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yury N Arlouski, MD (+375296374668, orl_doc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of bed-days (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.