HIPEC 101: Clinical Notes & Observations

“It is a well designed circuit and delivery system, and does exactly what it is designed to do:  deliver thermoregulated chemo-agents to patients at a Konstant rate and temperature for whatever duration the surgeon deems fit.”

Editor’s Note:

We hadn’t done a HIPEC procedure here in awhile, and although I had done HIPEC procedures before this, it was always in tandem with another perfusionist.  The last one was a first for both of us.  I felt comfortable enough in my own “skin” that this case represented a fun challenge, and better yet, we were using a system familiar to me- the HT-2000 from ThermaSolutions.

 

Glenn Keeling

ThermaSolutions is a solid company.  They do what they say they will do, and do it on time (even if it’s a last mintute thing…)  They delivered a HIPEC device as well as a technical specialist, Mr. Glenn Keeling, who in my opinion, is an amazing clinician, instructor, and communicator.  He obviously knows the entire concept, goes out of his way to develop deep trust and warm relationships with the surgeons, perfusion staff, and our hospital administrators.  I am rarely impressed, but on this day- my hat is off to Glenn for all the work he did in facilitating a smooth and tension-free operation.

While the objectivity of this blog precludes me from promoting one product over another, it does not stop me from extolling the virtues of this device and the relative ease it was in my eyes, to use and understand.  It is a well designed circuit and delivery system, and does exactly what it is designed to do:  deliver thermoregulated chemo-agents to patients at a Konstant rate and temperature for whatever duration the surgeon deems fit. 

Based on those criterion- (from a clinicians’ POV) I highly recommend this company as well as their product.

Below are some details of the process, a concise setup guide, and some clinical pointers for perfusionists/clinicians to review.

 

Step-By-Step Setup Guide by Glenn Keeling of ThermaSolutions

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Introduction to HIPEC

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Click image above to view source article.

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How HIPEC Works

HIPEC stands for Heated IntraPEritoneal Chemoperfusion, a procedure used to treat advanced abdominal cancers. You may have heard of HIPEC under another name: IPHC, chemo-bath, HIIC (heated intraoperative intraperitoneal chemotherapy), intraperitoneal chemohyperthermia, or continuous hyperthermic peritoneal perfusion.

Understanding HIPEC

HIPEC is performed at the end of surgery to remove abdominal tumors. Once all visible tumors have been removed (called “cytoreduction”), the surgeon continuously circulates a heated, sterile chemotherapy solution throughout the peritoneal cavity for up to 90 minutes. The HIPEC procedure is designed to attempt to kill any remaining cancer cells that cannot be seen. The solution is then removed and the incision closed.

Giving the chemotherapy in the abdomen at the time of surgery allows for greater concentrations of the drug where it is needed. Adding heat has a threefold advantage:

• Heat above 41 degrees Celsius more effectively kills cancer cells while having fewer effects on normal cells.
• Heat allows the chemotherapy to penetrate a few millimeters and kill cancer cells that cannot be seen.
• The chemotherapy dose can be higher than that given intravenously because it is not absorbed by the body in the same way. In this way, the normal side effects of chemotherapy can be avoided.

There is substantial clinical evidence that HIPEC is an effective treatment for patients with pseudomyxoma peritonei, mucinous adenocarcinoma of the appendix, and peritoneal mesothelioma. Additionally, peritoneal metastases from colon cancer can be successfully treated in a significant number of patients.

Clinical Notes:

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1. Cardioplegia set for thermoregulation
2. Reservoir
3. Prime line

 

Priming up the circuit!

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Getting into protective gear- (note the rebreather)

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Note:  The Ioban tape wrapped around the surgeons wrist to ensure no accidental seepage of chemo agent through the crease between the surgical gloves and gown.

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Be prepared to use and waste at least 10 liters of fluid

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Plz NOTE!  It is essential that you confirm with pharmacy the total volume of the chemo-perfusate.  To maintain proper concentrations (most often 3 liters of prime) if the drug is delivered in a 1000 cc bag, that volume will need to be taken off your priming volume in order to maintain desired concentration of the chemo agent.

BE Careful!

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Tyler (CCP) Adjusting Fluid return and Q rate

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Technique & Application

HIPEC

Purpose:

• Delivery of hyperthermic (42.5 degrees Celsius) chemo-therapeutic peritoneal lavage for an extended period of time (60-90 minutes) in order to neutralize and/or destroy residual tissue or cells containing malignant carcinoma, post surgical debulking of a malignant tumor in the abdomen or pelvis.
• Hyperthermia catalyzes the efficacy of the chemo-therapeutic agent, and potentiates targeting of cancer infected cells.

Equipment:

• Roller head pump
• Venous Reservoir
• AV loop- ¼” delivery and 3/8” return
• Fenestrated return tubing section (12 inch long segment of fenestrated 1/2″ tubing)
• “Y” tubing to facilitate both forward and return lavage flows throughout the target area, and return to allow continuous circulation of this chemo-therapeutic lavage for an extended period of time.
• “Quick Connect” male and female adaptors to reduce the potential for blood/chemo spills, or the need to cut in adaptors and connectors.
• Prime should constitute a 3 liter bag of peritoneal dialysis lavage solution that is typically employed for routine peritoneal dialysis.
• 6 Liters of pre-warmed H2O for use after the peritoneal lavage, to chase and eliminate remaining chemo-therapeutic agents in the abdominal cavity.
• A predefined process for where to shunt potential 10-12 liters for disposal or away from your circuit (if returning volume overload becomes an issue)

Cautionary Notes:

• The chemo-therapeutic drugs used in this procedure are potentially lethal or can cause significant harm if the clinician is inadequately protected or inadvertently exposed to direct contact with the drug, it’s residue, or slight skin contact.
• Respiratory re-breather circuits are a necessary precaution and MUST be worn.
• Eye protection is mandatory.
• Latex gloves should be worn as they are thicker and less susceptible to accidental tearing. Double gloving is a significant consideration.
• OR Suites are typically access restricted-with “No Entry” signs posted.
• Pregnancy is a contraindication for clinical involvement.
• It is essential that you confirm with pharmacy the total volume of the chemo-perfusate.  To maintain proper concentrations (most often 3 liters of prime) if the drug is delivered in a 1000 cc bag, that volume will need to be taken off your priming volume in order to maintain desired concentration of the chemo agent.

Perfusion Requirements:

• Thermoregulator/Delivery Device
  • Cardioplegia set with pressure monitoring capacity
  • Bubble trap/De-airing capability
    • Please note: Air is NOT an issue here- as it is basically a pump-in and pump-out chemical lavage of the abdominal cavity, with no intravascular communication or conduits in play.
  • Reservoir
  • Rapid prime line with 2 spikes
  • Volume shunting capability shifting Q from return reservoir- to a waste bag: Will need at least two 4 liter containers (Brat drainage bags are EXCELLENT for this purpose).  Note: The waste bags are “Y’d” together with a 3/8” Y connector so as to reduce exposure risk by not having to disconnect and reconnect waste bags as they fill up.
  • Pt Delivery temp monitoring
  • Pt Outlet temp monitoring

Procedure

• The HIPEC ECC should be primed and ready at least 1 hour prior to being deployed.
• Expect a reasonable 2-3 hours prior to HIPEC to allow for surgical debulking of tumor.
• Prime should constitute a 3 liter bag of peritoneal dialysis lavage solution that is typically employed for routine peritoneal dialysis.
• Prime should be warmed to roughly 44-45 degrees Celsius (assuming heat loss in transit to the patient body cavity).
• An AV loop to be opened and delivered sterilely to the operating field.
• An adjunct tubing kit- with “Y” capability, should be considered as an integral part of optimizing lavage inflow as well as outflow in order to ensure optimal intra-abdominal surface area contact with the chemo-therapeutic agent.
• When initiating the initial peritoneal lavage (no chemo agent added yet) you will probably need to deliver 5 liters before having enough volume in the abdominal cavity to establish full flow. Once you see abdominal distension, open your return line to begin recirculating the warm peritoneal diasylate.
• Typical Q rate is 1.5 to 2.0 LPM, at 42.5 degrees Celsius.
• The surgeon will instruct you as to when to add the chemo agent, and start your timer for the established period of time (60-90 minutes) that the surgeon wants you to lavage the abdomen.
• Have at least 6 liters of pre–warmed H2O ready to infuse into the system once the chemo run is completed.
• At the end of the chemo run, drain the patient’s abdomen have the Surgeon depress the belly to help empty as much of the chemo agent as possible.
• You will need to shunt this volume to waste bags, so that it is removed from the perfusate.
• Once your reservoir is empty, drop 6 liters of warm H20 into your reservoir, and fill the abdomen as you did earlier.
• Essentially, you are now just rinsing the abdomen to remove as much residual chemo agent as possible.
• Establish Q and after a few cycles, start to drain the patient’s abdomen when the perfusate looks clear.
• The Surgeon will assist by compressing the belly and once you are finished, he will suction out the remaining fluid into an outside suction source.
• When finished, your lines will be handed back, and all of your tubing and waste fluids must be handled with extreme caution and disposed of following the Hospital’s protocol.