Liver NeoplasmsPhase 2/3NCT01436721
Use of an Oxidized Regenerated Cellulose After Hepatic Surgery
A Phase 2/3 study testing Surgicel® absorbable Haemostat in people with Liver Neoplasms, run by Fudan University at 1 site in China.
Trial summary
Hepatectomy is one of the best treatments for malignant or benign lesions of the liver. The mortality and morbidity rates after hepatectomy have declined in recent years because of the precise measurement of liver functional reserve, a better understanding of liver anatomy, meticulous haemostasis during operation and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Surgicel® absorbable Haemostat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Dec 2011
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is 18 years to 70 Years
- The subject is undergoing major hepatectomy (right hemihepatectomy, right posterior sectionectomy, and right anterior sectionectomy) without concomitant operation on another organ or anastomosis between bile ducts, or bile ducts and the digestive tract, and no abdominal infection
- The subject is willing and able to provide appropriate informed consent
- The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
Who cannot join
- The subject is known or suspected to be pregnant (verified in a manner consistent with institution's standard of care), or is lactating
- The subject has an active infection at the surgical site
- The use of hemostatic agents are contraindicated for the subject
- The subject has a known bleeding disorder (including thrombocytopenia [< 100,000 platelet count], thromboasthenia, hemophilia, or von Willebrand disease)
- The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure
- The subject is unavailable for follow-up
- The subject is currently participating in another investigational device or drug trial
- Administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
zheng wang, MD, 64041990 ext. 64041990, wang.zheng@zs-hospital.sh.cn
Jia Fan, MD
About this study
Official title: The Randomized Clinical Trial of Surgicel® Absorbable Haemostat Covering the Raw Cut Surface During the Hepatectomy
Hepatectomy is one of the best treatments for malignant or benign lesions of the liver. The mortality and morbidity rates after hepatectomy have declined in recent years because of the precise measurement of liver functional reserve, a better understanding of liver anatomy, meticulous haemostasis during operation and improved postoperative management. Although surgical techniques have improved, life-threatening complications, such as intra-abdominal bleeding, bile leakage and subphrenic infection, now cannot be completed avoided. The local complications were most associated with the liver section treatment during the operation. Hence, the need for safer and more effective hemostatic treatment than the conventional approaches, such as intraoperative pressure by surgical gauze, ligatures, and electrocoagulation by mono- or bipolar instruments.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage barriers on section.
The present randomized clinical trial was designed to evaluate the efficacy and safety of Surgicel® absorbable Haemostat covering the raw cut surface during the hepatectomy.
Read the detailed description
This is a prospective, randomized, single-center investigation with a minimum of forty (40) controlled study subjects designed to evaluate the safety and effectiveness of the Surgicel® absorbable Haemostat as an absorbable hemostat in the hepatic surgical patient population.
Subjects who are undergoing hepatic surgical procedures should be considered for this investigation. The raw cut surface was covered with Surgicel® absorbable Haemostat or none but was dried by using fine sutures and an argon beam to achieve complete haemostasis. Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent. All subjects will be followed through their hospitalization. Follow-up evaluations will include time to removal of wound drain, the amount of effusion, length of postoperative hospital stay, and incidence of postoperative morbidity.
From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals.
- Conditions
- Liver Neoplasms
- Being tested
- Surgicel® absorbable Haemostat
- Keywords
- Effectiveness, Device success, Hepatectomy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgicel® absorbable HaemostatDevice
The raw cut surface was covered with Surgicel® absorbable Haemostat or none but was dried by using fine sutures and an argon beam to achieve complete haemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Surgicel® absorbable Haemostat | No intervention | Not described Receives: Device: Surgicel® absorbable Haemostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
the size of any subphrenic collection or pleural effusion
If large amounts of ascites developed, diuretics were given and the volume of infusion was limited. Before removed grainage tube, all patients were examined by ultrasonography performed by a doctor without knowledge of the study. The size of any subphrenic collection or pleural effusion was recorded. The drainage tube was removed when the leakage per 24 h was less than 50 cm3, the appearance of the secretion had changed from hematic to serous, and no bilious or infectious discharge was present, as determined by observation.
Measured: up time to the drainage tube removed, an expected average of 1 week
Secondary outcomes (3)
time to removal of wound drain
Measured: up time to removal of wound drain, an expected average of 1 week
length of postoperative hospital stay
Measured: up time to discharge from hospital,an expected average of 2 weeks
incidence of postoperative morbidity
After surgery, albumin, prophylactic broad-spectrum antibiotics, and enriched branched amino acid and fat emulsion (medium- and long-chain triglycerides), were given for 5-7 days until oral intake was possible.Ultrasonography-guided paracentesis or insertion of a second drainage tube was performed in patients with a subphrenic collection accompanied by fever (38.5◦C or higher) or a raised white blood cell count.
Measured: up time to discharge from hospital,an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Fan, Fudan University
- Investigators
- Jia Fan, MD, Principal investigator, Liver cancer institute, fudan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436721
- Sponsor's protocol ID
- LCI-125-001
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2011
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Clinical Trial of Surgicel® Absorbable Haemostat Covering the Raw Cut Surface During the Hepatectomy
- ClinicalTrials.gov ID
- NCT01436721
- Acronym / sponsor ID
- LCI-125-001
- Conditions
- Liver Neoplasms
- Keywords
- Effectiveness, Device success, Hepatectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 20 Sep 2011 (estimated)
- 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.
Hepatectomy is one of the best treatments for malignant or benign lesions of the liver. The mortality and morbidity rates after hepatectomy have declined in recent years because of the precise measurement of liver functional reserve, a better understanding of liver anatomy, meticulous haemostasis during operation and improved postoperative management. Although surgical techniques have improved, life-threatening complications, such as intra-abdominal bleeding, bile leakage and subphrenic infection, now cannot be completed avoided. The local complications were most associated with the liver section treatment during the operation. Hence, the need for safer and more effective hemostatic treatment than the conventional approaches, such as intraoperative pressure by surgical gauze, ligatures, and electrocoagulation by mono- or bipolar instruments.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage barriers on section.
The present randomized clinical trial was designed to evaluate the efficacy and safety of Surgicel® absorbable Haemostat covering the raw cut surface during the hepatectomy.
Detailed description
This is a prospective, randomized, single-center investigation with a minimum of forty (40) controlled study subjects designed to evaluate the safety and effectiveness of the Surgicel® absorbable Haemostat as an absorbable hemostat in the hepatic surgical patient population.
Subjects who are undergoing hepatic surgical procedures should be considered for this investigation. The raw cut surface was covered with Surgicel® absorbable Haemostat or none but was dried by using fine sutures and an argon beam to achieve complete haemostasis. Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent. All subjects will be followed through their hospitalization. Follow-up evaluations will include time to removal of wound drain, the amount of effusion, length of postoperative hospital stay, and incidence of postoperative morbidity.
From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgicel® absorbable Haemostat | No intervention | Device: Surgicel® absorbable Haemostat |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject is 18 years to 70 Years
- The subject is undergoing major hepatectomy (right hemihepatectomy, right posterior sectionectomy, and right anterior sectionectomy) without concomitant operation on another organ or anastomosis between bile ducts, or bile ducts and the digestive tract, and no abdominal infection
- The subject is willing and able to provide appropriate informed consent
- The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
Key exclusion criteria (8 listed)
- The subject is known or suspected to be pregnant (verified in a manner consistent with institution's standard of care), or is lactating
- The subject has an active infection at the surgical site
- The use of hemostatic agents are contraindicated for the subject
- The subject has a known bleeding disorder (including thrombocytopenia [< 100,000 platelet count], thromboasthenia, hemophilia, or von Willebrand disease)
- The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure
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 |
|---|---|---|
| Surgicel® absorbable HaemostatThe raw cut surface was covered with Surgicel® absorbable Haemostat or none but was dried by using fine sutures and an argon beam to achieve complete haemostasis. | Device | Surgicel® absorbable Haemostat |
Primary outcome
the size of any subphrenic collection or pleural effusion
Time frame: up time to the drainage tube removed, an expected average of 1 week
If large amounts of ascites developed, diuretics were given and the volume of infusion was limited. Before removed grainage tube, all patients were examined by ultrasonography performed by a doctor without knowledge of the study. The size of any subphrenic collection or pleural effusion was recorded. The drainage tube was removed when the leakage per 24 h was less than 50 cm3, the appearance of the secretion had changed from hematic to serous, and no bilious or infectious discharge was present, as determined by observation.
3 secondary outcomes
time to removal of wound drain
Time frame: up time to removal of wound drain, an expected average of 1 week
length of postoperative hospital stay
Time frame: up time to discharge from hospital,an expected average of 2 weeks
incidence of postoperative morbidity
Time frame: up time to discharge from hospital,an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
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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.
Jia Fan, MD principal investigator
Liver cancer institute, fudan university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Surgicel® absorbable Haemostat in people with Liver Neoplasms, run by Fudan University at 1 site in China.
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 4 inclusion and 8 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 20 Sep 2011. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the size of any subphrenic collection or pleural effusion (time frame: up time to the drainage tube removed, an expected average of 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 20 Sep 2011.