Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Hemopatch

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Age 18 years and above
• Able to give informed consent
• Suitable for minimally-invasive surgery

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemopatch; 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.	Device: Hemopatch; As stated in Hemopatch arm description
No Intervention: Control; The RARP and BPLND are performed in the usual manner. Hemopatch will not be applied to control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volume of drain output	Cumulative volume of output from the drain	Three days after the allocated treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day complications	Complications which occur within 30 days after the operation	Thirty days after the allocated treatment
Operating time	Duration of operation	Immediately post-operative
Blood loss	Volume of blood loss during operation	Immediately post-operative
Length of hospital stay	Patients undergoing robotic radical prostatectomy have an average hospital stay of three days	Three days after the allocated treatment
Duration of drainage	Number of days between insertion and removal of drain	Three days after the allocated treatment
Volume of drainage per post-operative day	Average volume of drain output per post-operative day	Three days after the allocated treatment
Transfusion requirement	Number of units of packed cells being transfused	Three days after the allocated treatment
Lymph node yield	Number of lymph nodes yielded upon pelvic lymph node dissection	One week after the allocated treatment

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Jeremy Yuen Chun TEOH, MBBS, FRCSEd, Chinese University of Hong Kong

Publications and helpful links

General 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.
• Fossati 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.
• Gilbert 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.
• Simonato 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.
• Lewis 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Prostate cancer; Hemopatch
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CRE 2019.419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No