Prostate CancerNCT04185922
Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection
A study testing Hemopatch in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Robotic prostatectomy (RARP) is a surgery for treatment localized prostate cancer. Bilateral pelvic lymph node dissection (BPLND) will also be performed if there is an estimated risk of occult nodal metastases exceeding 5%. BPLND in general is a well-tolerated procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hemopatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Feb 2020to 10 Jun 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and above
- Able to give informed consent
- Suitable for minimally-invasive surgery
Who cannot join
- Known allergy or hypersensitivity to any component of Hemopatch®
- Known hypersensitivity to bovine proteins or brilliant blue
- Patients with prior pelvic radiotherapy
- Patients with non-correctable coagulopathy
- Patients who are on anticoagulants
- Contraindication to general anaesthesia
- Previous transurethral resection of the prostate or prostatic surgery
- Untreated active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection: a Randomized Controlled Trial
Robotic prostatectomy (RARP) is a surgery for treatment localized prostate cancer. Bilateral pelvic lymph node dissection (BPLND) will also be performed if there is an estimated risk of occult nodal metastases exceeding 5%. BPLND in general is a well-tolerated procedure. Lymphatic leak is one of the possible complications after lymph node dissection (BPLND). Lymphocele is a collection of lymphatic fluid after operation. Hemopatch is a material used during operation that may prevent lymphorrhoea. This is a randomizedcontrolled trial that aims at investigating the application of Hemopatch to raw lymphatic tissue in preventing lymphorrhoea. Patients would be divided into 2 groups: with or without the use of Hemopatch during operation. They will be followed up on day 30 to monitor the course of recovery and any complications.
Read the detailed description
In prostate cancer patients undergoing robot-assisted radical prostatectomy (RARP), the current European Association of Urology (EAU) prostate cancer guidelines recommend bilateral pelvic lymph node dissection (BPLND) for those with an estimated risk of occult nodal metastases exceeding 5%.(1) In a systematic review of 66 studies involving 275, 269 patients, lymphadenectomy can identify node positive patients who may benefit from adjuvant treatment (2).
BPLND in general is a well-tolerated procedure. However, when complications do occur, significant morbidity results. The benefits of BPLND must be carefully weighed against its potential complications. The most common complication of BPLND is lymphocoele formation. Lymphatic vessels have no muscular layer as opposed to blood vessels. Transection of a blood vessel will lead to vasoconstriction and eventual cessation of bleeding. This is not the case with lymphatic vessels, and transection will lead to prolonged lymphorrhoea. The incidence of lymphocoele varies from series to series, ranging from 0.8% to 33%, depending on the extent of lymphadenectomy, surgical technique, operative approach, and the diagnostic approach (3,4). The most common symptoms are pelvic pain, abdominal distension, lower extremity or scrotal oedema, lower urinary tract symptom, frank bladder outlet obstruction, sepsis and even anastomotic disruption. Prolonged lymphorrhoea lengthens hospital stay, places the patient at risk for nosocomial infection and has significant cost implications for the healthcare system.
Hemopatch is a haemostatic pad consisting of a collagen sheet derived from bovine dermis with an NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate) coated active surface. These two components act together to provide effective tissue adherence, sealing and haemostasis (5). Upon tissue contact, NHS-PEG molecules on the active surface form covalent bonds with tissue proteins. Cross-linking NHS-PEG and proteins forms a hydrogel which acts as an effective tissue seal. Older generation NHS-PEG products in the form of solutions of flowable sealants are quickly washed away by blood or other leaking body fluids, rendering them ineffective in the presence of active bleeding or fluid leakage. Hemopatch is a novel NHSPEG delivery vehicle designed to overcome this limitation. Due to the open pore structure of the collagen, excess tissue fluids are readily absorbed and direct contact of NHS-PEG to tissue surface can be achieved. The collagen pad is optimized to be soft, thin, pliable, and has a high liquid absorption capacity. The pad is resorbed and replaced by host tissue in six to eight weeks with little tissue reaction.
The investigators hypothesise that the application of Hemopatch to raw lymphatic tissue can prevent lymphorrhoea through its unique combination of tissue adherence, sealing and fluid absorption. This can potentially prevent lymphatic leak, reduce drain output and facilitate earlier discharge.
- Conditions
- Prostate Cancer
- Being tested
- Hemopatch
- Keywords
- Prostate cancer, Hemopatch
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopatchDevice
As stated in Hemopatch arm description
| Study group | Role | What they receive |
|---|---|---|
| Hemopatch | Experimental | The RARP and BPLND are performed in the usual manner. Towards the end of the operation, Hemopatch is laid over the ends of raw truncated lymphatic tissue. Receives: Device: Hemopatch |
| Control | No intervention | The RARP and BPLND are performed in the usual manner. Hemopatch will not be applied to control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of drain output
Cumulative volume of output from the drain
Measured: Three days after the allocated treatment
Secondary outcomes (8)
Operating time
Duration of operation
Measured: Immediately post-operative
Blood loss
Volume of blood loss during operation
Measured: Immediately post-operative
Duration of drainage
Number of days between insertion and removal of drain
Measured: Three days after the allocated treatment
Volume of drainage per post-operative day
Average volume of drain output per post-operative day
Measured: Three days after the allocated treatment
Length of hospital stay
Patients undergoing robotic radical prostatectomy have an average hospital stay of three days
Measured: Three days after the allocated treatment
Transfusion requirement
Number of units of packed cells being transfused
Measured: Three days after the allocated treatment
Lymph node yield
Number of lymph nodes yielded upon pelvic lymph node dissection
Measured: One week after the allocated treatment
30-day complications
Complications which occur within 30 days after the operation
Measured: Thirty days after the allocated treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start27 Feb 2020
- Primary completion21 Jul 2021
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective; single-centre phase 3 randomised controlled trial conducted to investigate the efficacy of Hemopatch for preventing lymphatic leak after RARP and BPLND.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Yuen Chun TEOH, Chinese University of Hong Kong
- Investigators
- Jeremy Yuen Chun Teoh, MBBS, FRCSEd, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185922
- Sponsor's protocol ID
- CRE 2019.419
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
PubMed 27568654Fossati N, Willemse PM, Van den Broeck T, van den Bergh RCN, Yuan CY, Briers E, Bellmunt J, Bolla M, Cornford P, De Santis M, MacPepple E, Henry AM, Mason MD, Matveev VB, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Lam TB, Mottet N, Joniau S. The Benefits and Harms of Different Extents of Lymph Node Dissection During Radical Prostatectomy for Prostate Cancer: A Systematic Review. Eur Urol. 2017 Jul;72(1):84-109. doi: 10.1016/j.eururo.2016.12.003. Epub 2017 Jan 24.
PubMed 28126351Gilbert DR, Angell J, Abaza R. Evaluation of Absorbable Hemostatic Powder for Prevention of Lymphoceles Following Robotic Prostatectomy With Lymphadenectomy. Urology. 2016 Dec;98:75-80. doi: 10.1016/j.urology.2016.06.071. Epub 2016 Sep 1.
PubMed 27592524Simonato A, Varca V, Esposito M, Venzano F, Carmignani G. The use of a surgical patch in the prevention of lymphoceles after extraperitoneal pelvic lymphadenectomy for prostate cancer: a randomized prospective pilot study. J Urol. 2009 Nov;182(5):2285-90. doi: 10.1016/j.juro.2009.07.033. Epub 2009 Sep 16.
PubMed 19762048Lewis KM, Kuntze CE, Gulle H. Control of bleeding in surgical procedures: critical appraisal of HEMOPATCH (Sealing Hemostat). Med Devices (Auckl). 2015 Dec 22;9:1-10. doi: 10.2147/MDER.S90591. eCollection 2016.
PubMed 26730213
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04185922
- Acronym / sponsor ID
- CRE 2019.419
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Hemopatch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 4 Dec 2019 (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.
Robotic prostatectomy (RARP) is a surgery for treatment localized prostate cancer. Bilateral pelvic lymph node dissection (BPLND) will also be performed if there is an estimated risk of occult nodal metastases exceeding 5%. BPLND in general is a well-tolerated procedure. Lymphatic leak is one of the possible complications after lymph node dissection (BPLND). Lymphocele is a collection of lymphatic fluid after operation. Hemopatch is a material used during operation that may prevent lymphorrhoea. This is a randomizedcontrolled trial that aims at investigating the application of Hemopatch to raw lymphatic tissue in preventing lymphorrhoea. Patients would be divided into 2 groups: with or without the use of Hemopatch during operation. They will be followed up on day 30 to monitor the course of recovery and any complications.
Detailed description
In prostate cancer patients undergoing robot-assisted radical prostatectomy (RARP), the current European Association of Urology (EAU) prostate cancer guidelines recommend bilateral pelvic lymph node dissection (BPLND) for those with an estimated risk of occult nodal metastases exceeding 5%.(1) In a systematic review of 66 studies involving 275, 269 patients, lymphadenectomy can identify node positive patients who may benefit from adjuvant treatment (2).
BPLND in general is a well-tolerated procedure. However, when complications do occur, significant morbidity results. The benefits of BPLND must be carefully weighed against its potential complications. The most common complication of BPLND is lymphocoele formation. Lymphatic vessels have no muscular layer as opposed to blood vessels. Transection of a blood vessel will lead to vasoconstriction and eventual cessation of bleeding. This is not the case with lymphatic vessels, and transection will lead to prolonged lymphorrhoea. The incidence of lymphocoele varies from series to series, ranging from 0.8% to 33%, depending on the extent of lymphadenectomy, surgical technique, operative approach, and the diagnostic approach (3,4). The most common symptoms are pelvic pain, abdominal distension, lower extremity or scrotal oedema, lower urinary tract symptom, frank bladder outlet obstruction, sepsis and even anastomotic disruption. Prolonged lymphorrhoea lengthens hospital stay, places the patient at risk for nosocomial infection and has significant cost implications for the healthcare system.
Hemopatch is a haemostatic pad consisting of a collagen sheet derived from bovine dermis with an NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate) coated active surface. These two components act together to provide effective tissue adherence, sealing and haemostasis (5). Upon tissue contact, NHS-PEG molecules on the active surface form covalent bonds with tissue proteins. Cross-linking NHS-PEG and proteins forms a hydrogel which acts as an effective tissue seal. Older generation NHS-PEG products in the form of solutions of flowable sealants are quickly washed away by blood or other leaking body fluids, rendering them ineffective in the presence of active bleeding or fluid leakage. Hemopatch is a novel NHSPEG delivery vehicle designed to overcome this limitation. Due to the open pore structure of the collagen, excess tissue fluids are readily absorbed and direct contact of NHS-PEG to tissue surface can be achieved. The collagen pad is optimized to be soft, thin, pliable, and has a high liquid absorption capacity. The pad is resorbed and replaced by host tissue in six to eight weeks with little tissue reaction.
The investigators hypothesise that the application of Hemopatch to raw lymphatic tissue can prevent lymphorrhoea through its unique combination of tissue adherence, sealing and fluid absorption. This can potentially prevent lymphatic leak, reduce drain output and facilitate earlier discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective; single-centre phase 3 randomised controlled trial conducted to investigate the efficacy of Hemopatch for preventing lymphatic leak after RARP and BPLND.
| Arm | Type | Receives |
|---|---|---|
| Hemopatch | Experimental | Device: HemopatchThe RARP and BPLND are performed in the usual manner. Towards the end of the operation, Hemopatch is laid over the ends of raw truncated lymphatic tissue. |
| Control | No intervention | –The RARP and BPLND are performed in the usual manner. Hemopatch will not be applied to control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and above
- Able to give informed consent
- Suitable for minimally-invasive surgery
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to any component of Hemopatch®
- Known hypersensitivity to bovine proteins or brilliant blue
- Patients with prior pelvic radiotherapy
- Patients with non-correctable coagulopathy
- Patients who are on anticoagulants
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 |
|---|---|---|
| HemopatchAs stated in Hemopatch arm description | Device | Hemopatch |
Primary outcome
Total volume of drain output
Time frame: Three days after the allocated treatment
Cumulative volume of output from the drain
8 secondary outcomes
Operating time
Time frame: Immediately post-operative
Blood loss
Time frame: Immediately post-operative
Duration of drainage
Time frame: Three days after the allocated treatment
Volume of drainage per post-operative day
Time frame: Three days after the allocated treatment
Length of hospital stay
Time frame: Three days after the allocated treatment
Transfusion requirement
Time frame: Three days after the allocated treatment
Lymph node yield
Time frame: One week after the allocated treatment
30-day complications
Time frame: Thirty days after the allocated treatment
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 27 Oct 2026.
- Background: PubMed 27568654Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
- Background: PubMed 28126351Fossati N, Willemse PM, Van den Broeck T, van den Bergh RCN, Yuan CY, Briers E, Bellmunt J, Bolla M, Cornford P, De Santis M, MacPepple E, Henry AM, Mason MD, Matveev VB, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Lam TB, Mottet N, Joniau S. The Benefits and Harms of Different Extents of Lymph Node Dissection During Radical Prostatectomy for Prostate Cancer: A Systematic Review. Eur Urol. 2017 Jul;72(1):84-109. doi: 10.1016/j.eururo.2016.12.003. Epub 2017 Jan 24.
- Background: PubMed 27592524Gilbert DR, Angell J, Abaza R. Evaluation of Absorbable Hemostatic Powder for Prevention of Lymphoceles Following Robotic Prostatectomy With Lymphadenectomy. Urology. 2016 Dec;98:75-80. doi: 10.1016/j.urology.2016.06.071. Epub 2016 Sep 1.
- Background: PubMed 19762048Simonato A, Varca V, Esposito M, Venzano F, Carmignani G. The use of a surgical patch in the prevention of lymphoceles after extraperitoneal pelvic lymphadenectomy for prostate cancer: a randomized prospective pilot study. J Urol. 2009 Nov;182(5):2285-90. doi: 10.1016/j.juro.2009.07.033. Epub 2009 Sep 16.
- Background: PubMed 26730213Lewis KM, Kuntze CE, Gulle H. Control of bleeding in surgical procedures: critical appraisal of HEMOPATCH (Sealing Hemostat). Med Devices (Auckl). 2015 Dec 22;9:1-10. doi: 10.2147/MDER.S90591. eCollection 2016.
- 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.
Jeremy Yuen Chun Teoh, MBBS, FRCSEd principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemopatch in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 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: finished, as of the sponsor's last update on 27 Oct 2026. 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 Hong Kong. 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.
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?
Total volume of drain output (time frame: Three days after the allocated treatment). 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 NCT04185922, which also lists 5 linked publications.
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 27 Oct 2026.