Liver TransplantNCT04504487
Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy
A study testing Drain Removal in people with Liver Transplant, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
It's a randomized control trial to compare early drain removal versus standard drain removal after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate the safety of early drain removal using 3x3 rule with routine drain removal. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Drain Removal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteIndia
- Study dates
- 28 Jan 2021to 25 Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Donors evaluated as per institutional protocol for donor hepatectomy and found fit
- Those who consent
Who cannot join
- Patients refusing to consent for inclusion in the study.
- Left lateral hepatectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".
It's a randomized control trial to compare early drain removal versus standard drain removal after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate the safety of early drain removal using 3x3 rule with routine drain removal.
Read the detailed description
- Prophylactic abdominal drainage after donor right hepatectomy for LDLT has been a common or even mandatory practice in most transplant centres.
- This serves to monitor the occurrence of postoperative intraabdominal bleeding and is used for the detection and drainage of any bile leakage.
- Below table mentions both advantages and disadvantages of prophylactic drain placement after hepatectomy.
Advantages
- Early detection of haemorrhage
- Early detection of bile leak
- Early reintervention Disadvantages
- Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3. Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.
- Our study in ILBS for ALF donors, the overall complication rate was 20% as per Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2 complications. Major complications (3b and above) were seen in 4 (1.0%) patients. Biliary complications were noted in 1.7% only.
- In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows for the early removal of the drain tube with minimum infection risk after liver resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin concentration is <3 mg/dl on day 3 after operation.
- In our institute we remove drain routinely, when output is less than 100ml and serous. That is usually on postoperative day 5-7.
- There is no randomized control trail done in donor hepatectomy comparing early versus standard drain removal.
- Conditions
- Liver Transplant
- Being tested
- Drain Removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drain RemovalOther
Abdominal drain placed during surgery removal
| Study group | Role | What they receive |
|---|---|---|
| Early drain removal - POD3 | Experimental | Drain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature. Receives: Other: Drain Removal |
| Routine Drain Removal | Placebo comparator | Drain removed routinely when the output is less than 100ml and serous in nature Receives: Other: Drain Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of drain removal using 3x3 rule - overall complications.
Comprehensive complication index (CCI) - clavin dindo classification
Measured: patient will be followed upto 3 months after surgery
Secondary outcomes (6)
Post operative pain relief
using Visual analogue score
Measured: patient will be followed upto 3 months after surgery
Bile leak
standard ISGLS definition - drain bilirubin measured in mg/dl.
Measured: patient will be followed upto 3 months after surgery
Length of hospital stay
calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital
Measured: patient will be followed upto 3 months after surgery
Surgical Site Infection (SSI)
patient has at least one of the following:
- purulent drainage from the superficial incision.
- organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)).
- superficial incision that is deliberately opened by a surgeon, physician* or physician designee and culture or non-culture based testing of the superficial incision or subcutaneous tissue is not performed AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat.
- diagnosis of a superficial incisional SSI by a physician* or physician designee.
Measured: patient will be followed upto 3 months after surgery
reintervention rate
defined as any additional abdominal intervention ( surgical or radiological) during the same hospital stay after the primary operation
Measured: patient will be followed upto 3 months after surgery
readmission rate
90 day readmission rate - any hospital admission after the index admission.
Measured: patient will be followed upto 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start28 Jan 2021
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504487
- Sponsor's protocol ID
- ILBS/LIVEDONORS/01
- Status last verified
- Jan 2022
- First submitted
- 30 Jul 2020
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durairaj P, Pamecha V, Mohapatra N, Patil NS, Sindwani G. Early drain removal after live liver donor hepatectomy is safe - a randomized controlled pilot study. Langenbecks Arch Surg. 2023 Sep 5;408(1):350. doi: 10.1007/s00423-023-03088-9.
PubMed 37670194
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".
- ClinicalTrials.gov ID
- NCT04504487
- Acronym / sponsor ID
- ILBS/LIVEDONORS/01
- Conditions
- Liver Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 7 Aug 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.
It's a randomized control trial to compare early drain removal versus standard drain removal after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate the safety of early drain removal using 3x3 rule with routine drain removal.
Detailed description
- Prophylactic abdominal drainage after donor right hepatectomy for LDLT has been a common or even mandatory practice in most transplant centres.
- This serves to monitor the occurrence of postoperative intraabdominal bleeding and is used for the detection and drainage of any bile leakage.
- Below table mentions both advantages and disadvantages of prophylactic drain placement after hepatectomy.
Advantages
- Early detection of haemorrhage
- Early detection of bile leak
- Early reintervention Disadvantages
- Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3. Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.
- Our study in ILBS for ALF donors, the overall complication rate was 20% as per Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2 complications. Major complications (3b and above) were seen in 4 (1.0%) patients. Biliary complications were noted in 1.7% only.
- In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows for the early removal of the drain tube with minimum infection risk after liver resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin concentration is <3 mg/dl on day 3 after operation.
- In our institute we remove drain routinely, when output is less than 100ml and serous. That is usually on postoperative day 5-7.
- There is no randomized control trail done in donor hepatectomy comparing early versus standard drain removal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early drain removal - POD3 | Experimental | Other: Drain RemovalDrain removal on POD3 if drain bilirubin is less than 3mg/dl and serous in nature. |
| Routine Drain Removal | Placebo comparator | Other: Drain RemovalDrain removed routinely when the output is less than 100ml and serous in nature |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Donors evaluated as per institutional protocol for donor hepatectomy and found fit
Key exclusion criteria (2 listed)
- Patients refusing to consent for inclusion in the study.
- Left lateral hepatectomy.
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 |
|---|---|---|
| Drain RemovalAbdominal drain placed during surgery removal | Other | Early drain removal - POD3, Routine Drain Removal |
Primary outcome
safety of drain removal using 3x3 rule - overall complications.
Time frame: patient will be followed upto 3 months after surgery
Comprehensive complication index (CCI) - clavin dindo classification
6 secondary outcomes
Post operative pain relief
Time frame: patient will be followed upto 3 months after surgery
Bile leak
Time frame: patient will be followed upto 3 months after surgery
Length of hospital stay
Time frame: patient will be followed upto 3 months after surgery
Surgical Site Infection (SSI)
Time frame: patient will be followed upto 3 months after surgery
reintervention rate
Time frame: patient will be followed upto 3 months after surgery
readmission rate
Time frame: patient will be followed upto 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Derived from this study: PubMed 37670194Durairaj P, Pamecha V, Mohapatra N, Patil NS, Sindwani G. Early drain removal after live liver donor hepatectomy is safe - a randomized controlled pilot study. Langenbecks Arch Surg. 2023 Sep 5;408(1):350. doi: 10.1007/s00423-023-03088-9.
- Prospective Validation of Optimal Drain Management "The 3 × 3 Rule" after Liver ResectionLink provided by the sponsor.
- Living Donor Liver Transplantation for Acute Liver Failure: Donor Safety and Recipient OutcomeLink provided by the sponsor.
- Criteria for drain removal following liver resectionLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drain Removal in people with Liver Transplant, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of drain removal using 3x3 rule - overall complications. (time frame: patient will be followed upto 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04504487, which also lists 1 linked publication.
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 13 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.