The Chicago Consensus on peritoneal surface malignancies: Standards
The Chicago Consensus Working Group provides the following multidisciplinary recommendations for the care of patients with peritoneal surface malignancies. This article focuses on the standards of a peritoneal surface malignancy center, standards of billing and coding, standards of operative reports for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, standards of cytoreductive surgery training, and standards of intraoperative chemotherapy preparation. These guidelines are developed with input from leading experts, including surgical oncologists, medical oncologists, pathologists, radiologists, palliative care physicians, and pharmacists. These guidelines recognize and address the emerging need for increased awareness in the appropriate management of peritoneal surface disease. They are not intended to replace the quest for higher levels of evidence.
This article provides multidisciplinary recommendations pertaining to the care of patients with peritoneal surface malignancies and constitutes 1 article in a series composed by the Chicago Consensus Working Group for the Management of Peritoneal Surface Malignancies. 1-10 Information regarding the formation of the Chicago Consensus Group and an explanation of the working group's consensus methodology is discussed. 1, 2
Standards of a Peritoneal Surface Malignancy Center
A peritoneal surface malignancy center provides specialized care for patients with peritoneal surface diseases. To provide safe and effective care for patients with this complex set of diseases, it is essential for aspiring centers to create an environment that is conducive to providing patient-centered care.
A peritoneal surface malignancy center must have the expertise of dedicated physicians, nurses, and staff members and adequate facilities for delivering care while maintaining safety standards.11
- The institution must have a defined surgical leader. The leader must have board eligibility or certification in general surgery, colorectal surgery, surgical oncology, or gynecologic oncology. The leader must also have demonstrated significant experience in cytoreductive surgical procedures (including visceral resections and peritonectomy procedures), chemotherapy delivery and safety in the operating room (OR), and management of hyperthermic fluid delivery. Experience will be demonstrated through the following:
- ◦ Documented fellowship experience with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) (see the Standards of CRS Training section)
- ◦ Documentation of the requisite number of proctored/mentored cases in CRS/HIPEC
- ◦ Documentation of the number of CRS/HIPEC cases performed per year
- A second board-eligible/certified surgeon must be available for operative and postoperative assistance/coverage.
- A multidisciplinary team must have a minimum of 1 named member from each of the following specialties: surgery, pathology, radiology, medical oncology (required), patient tracker/navigator, oncology-certified nurses, and psychosocial support staff (preferred).
- The institution must be a member of the American College of Surgeons Commission on Cancer or a National Cancer Institute–designated cancer center.
- The institution's pathology laboratory must be accredited by the College of American Pathologists.
- The institution's magnetic resonance imaging (MRI) facility must be accredited by the American College of Radiology.
- The institution must have continuously available intensive care unit (ICU) and blood bank support.
- A pharmacist with expertise in chemotherapy for drug preparation must be available.
- The institution must have 24-hour availability of interventional radiology and complex endoscopy.12
- Tissue diagnosis confirmed prior to treatment (target rate >95%)
- Tumor markers (if relevant) obtained prior to surgery (target rate >95%)
- Cross-sectional imaging of the abdomen and pelvis obtained and reviewed less than 90 days prior to surgery (target rate 100%)
- Data from patients entered into institutional database (target rate 100%)
- Informed consent for surgery and chemotherapy obtained preoperatively (target rate 100%)
- Chemotherapy drugs labeled with (at a minimum) patient name, second patient identifier (such as medical record number), generic drug name, dose, volume of solution, and date/time of drug preparation (target rate 100%)13
- Twelve or more CRS/HIPEC cases performed per surgeon per year:
- ◦ For centers seeking to become designated peritoneal surface malignancy centers, this benchmark will be met during year 3.
- Operative report dictation less than 24 hours after procedure (target rate 100%)
- Standardized synoptic pathology report issued within 2 weeks of surgery (target rate 90%)
- Monitoring of perfusate temperature during HIPEC (target rate 100%)
- Intraoperative core temperature monitoring (target rate 100%)
- Perfusion apparatus monitored throughout procedure (target rate 100%)
- Rate of complete cytoreduction (CC0/CC1) greater than 60% (required)
- Target 30-day mortality less than 5%
- Target ostomy rate (permanent or temporary) at index operation or as a result of subsequent complication less than 25%
- Hospital stay of less than 14 days (target rate >50%)
- ICU stay of less than 48 hours (target rate >50%)
- Target transfusion rate less than 50%
- Target readmission rate less than 33%
- Target rate of major complications less than 40%
Standards of Billing and Coding
Currently, the practice of CRS (specifically, peritonectomy procedures) with or without intraperitoneal chemotherapy does not have clearly defined procedural terminology codes. Given this variability, which is influenced by locoregional hospital and payer differences (eg, negotiated contracts with or without specific bundling practices), it is critical that providers optimize their documentation—in close collaboration with institutional coding experts—to ensure fiscal viability of CRS/HIPEC programs. This document aims to provide guidance regarding certain standards in the billing and coding of these procedures.
Large-volume institutions have adopted 2 major strategies to account for work effort for CRS with or without intraperitoneal chemotherapy. These are 1) “bundled” work effort regardless of visceral resections performed and 2) additive individual procedures with or without discounting for additive procedures.
Accounting for the effort involved in administering intraperitoneal chemotherapy along with the preoperative counseling and postoperative care (although generally included as part of the “global” period) is less clear. Some institutions use administration of chemotherapy, hyperthermia, and insertion of tunneled catheter as combined codes for capturing work effort. Other institutions (on the basis of formal consulting agreements) have developed an imputed value for such relative value units.
- Ensuring that pre-, intra-, and postoperative documentation specifically and accurately reflects severity of illness (SOI) and risk of mortality (ROM), which are translated into International Classification of Diseases, Tenth Revision diagnosis and procedure codes. Examples of documentation opportunities include the following:
- ◦ Electrolyte disturbances
- ◦ Acute blood loss anemia
- ◦ Metastatic cancer sites
- ◦ Malnutrition (and severity of malnutrition)
- ◦ Obesity/body mass index
- Reinforcing the importance of thorough and accurate documentation with nonsurgical colleagues (case managers/social workers, nurses, dieticians, etc) and other health care providers (advanced practice providers, residents, etc).
- Clearly documenting visceral resections performed, especially if these are billed separately by procedure performed. Even if they are bundled, they should be documented clearly for optimal patient care.
- Specificity about the peritonectomy procedures performed, including size of tumor resection (billed as unlisted codes). Many institutions have created internal “dummy” codes with associated relative value units for each procedure (eg, 58957 for pelvic peritonectomy, 58950 for hemidiaphragmatic/paracolic peritonectomy, or both).
- Omentectomy with description of the omental cake size. Many institutions, as guided by the National Correct Coding Initiative, have the omentectomy bundled into the cytoreduction unless it is the only procedure performed.
- Ureterolysis, if performed, and the level of complexity. Many institutions, however, have this irreversibly bundled into other procedures.
- Degree of complexity of the operation (duration, need for 2 surgeons, repeat surgery that may lead to the use of modifier 22).
- Specific details regarding the generation of hyperthermia, nature of chemoperfusate, and need for clinical vigilance during the chemoperfusion if performed.
- Details of abdominal wall resection and reconstruction, including separation of components if performed.
- Extent of any diaphragm resection, with repair.
- Ensure that documentation reflects the patient's true SOI and ROM.
- Identify modifiable risk factors that optimize the degree of complexity of the risk-adjusted model (all patient refined diagnosis-related group [DRG]):
- ◦ Complication/comorbidity: a significant acute disease, significant acute manifestation of a chronic disease, advanced or end-stage chronic disease, or chronic disease associated with systemic physiological decompensation and debility that has consistently greater impact on hospital resources. Examples include acidosis, acute renal failure, postoperative ileus, urinary tract infection, stage 4 chronic kidney disease, and chronic systolic congestive heart failure.
- ◦ Major complication/comorbidity: diagnosis codes that reflect the highest level of severity, leading to substantially increased hospital resource use, such as intensive monitoring, expensive and technically complex services, and extensive care requiring a greater number of caregivers. Examples include acute diastolic heart failure, acute tubular necrosis, acute respiratory failure, sepsis, pneumonia, pulmonary embolism, and end-stage renal disease.
- ◦ Relative weight: an assigned weight that is intended to reflect the relative resource consumption associated with each DRG. The higher the relative weight is, the more resources it takes to care for that patient.
- ◦ HIPEC/intraperitoneal chemotherapy procedure codes do not impact DRG assignment today. The CRS drives the DRG assignment. The HIPEC/intraperitoneal chemotherapy procedure is considered medical, not surgical, for DRG assignment.
- Recognize that when patients undergo a 4-quadrant peritonectomy but have limited visceral resection such as an appendectomy, current software classifiers categorize these cases as appendectomies only.
Standards of CRS and HIPEC Operative Reports
- Patient and surgeon details.
- Diagnosis: It is recommended to use standardized terminology indicating the histology of disease (such as low-grade carcinoma peritonei from low-grade appendiceal mucinous neoplasm [LAMN] rather than the generic term pseudomyxoma peritonei).
- Anesthetic procedures: Documentation of the use of regional anesthesia and significant anesthetic considerations, including fluids administered and blood loss, is recommended.
- Procedures performed: The use of laparoscopy, including the site for the ports, peritonectomy procedures, visceral resections, diversion procedures, and use of intraperitoneal chemotherapy with duration, temperature, and flow rate of perfusion should be documented. The performance of reconstructive procedures must also be clearly described. The completeness of cytoreduction (CCR) must be documented by using either the completeness of cytoreduction score or the R score. Ablative procedures such as electroevaporative surgery, ultrasonic aspiration, or laser ablation must be described with areas of use. Such procedures by nature do not result in complete (CC0 or R0) cytoreduction and must be indicated as CC1 or CC2 (or R1 or R2a/b).
- Findings: A clear description of peritoneal disease burden and distribution must be provided and must include a detailed assessment of the Morison pouch, right coronary ligaments, retrosplenic space, pelvic cul-de-sac, and seromesenteric junctions. Documentation using a well-described scoring system such as the peritoneal cancer index (PCI), simplified PCI, or Gilly score is recommended.
Template of Operative Report
Medical record number:
Date of birth:
Date of surgery:
- Primary origin of carcinomatosis:
- Synchronous or metachronous carcinomatosis:
- Preoperative imaging:
- Preoperative chemotherapy: Y/N
- Eastern Cooperative Oncology Group performance status:
- American Society of Anesthesiologists class:
- Preoperative deep vein thrombosis prophylaxis:
- Preoperative antibiotics: Y/N, type:
- Preoperative ureteral stents: Y/N
- Laparoscopy before exploration: Y/N
- PCI index/distribution/lesions, size, range, locations:
- Ascites present: Y/N, volume:
- Peritonectomy sites:
- Organs resected:
- Number of anastomoses:
- Loop or end stoma:
- CCR or R score:
- Open or closed technique:
- Type and dose of chemotherapy:
- Inflow/outflow temperature probes:
- Perfusate temperature at outflow:
- Perfusate fluid volume and flow rate:
- Perfusion time:
- Extubated in OR/intubated:
- Estimated blood loss:
- Fluids administered:
- Disposition: ICU/floor
Dictate your narrative operative report with any additional details.
Standards of CRS Training
Purpose of CRS Training
- Patient care
- Medical knowledge
- Practice-based learning and improvement
- Interpersonal and communication skills
- Systems-based practice
Recommendations Regarding the Nature of CRS Training
The purpose of CRS training is to confirm that the recipient has received adequate education and training in the technical aspects of CRS, patient selection for CRS, and the postoperative management of patients after cytoreduction.
Clinical Experience Requirements
Active participation in the treatment of 20 patients with peritoneal surface malignancies is recommended. The following areas are covered:
- Preoperative evaluation, assessment, and counseling of patients
- Perioperative in-hospital care
- Postoperative outpatient follow-up
- Multidisciplinary tumor boards
- Morbidity and mortality conference
- Discussion of advanced directives and living will
- Management and palliation of advanced malignancies
- Familiarity with intra-abdominal computed tomography (CT) and MRI, with specific attention to the peritoneum and mesentery
Technical Components of the Surgery
- Expertise in visceral resections, including splenectomy, colon and rectal resections, and gastric, small bowel, pancreas, and liver resections, is required.
- Expertise in peritonectomy procedures is required.
- Expertise in ablative techniques such as electroevaporative surgery, argon laser ablation, and ultrasonic aspiration is required.
- Expertise in hysterectomy and bilateral salpingo-oophorectomy and bladder resections is preferred.
- Continuing education:
- ◦ Participation in national educational conferences (eg, Society of Surgical Oncology Advanced Cancer Therapies meeting)
- ◦ Participation in multicenter clinical discussions (eg, University of Pittsburgh Medical Center regional perfusion videoconference)
- Surgeon's role: To achieve independent expertise in CRS, it is recommended that the surgeon be the primary surgeon for at least 70% of the cases (Table 1).
|Type of Procedure
|Recommended Case No.
|Overall cytoreductive surgery cases
Standards for the Preparation of Intraoperative Chemotherapy
Best-practice chemotherapy standards exist for the safe prescribing, preparation, and administration of chemotherapy. Published standards by the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society address parenteral and oral routes of chemotherapy, whether administered in an ambulatory or inpatient setting.1 The OR poses a unique environment, with relative unfamiliarity of the delivery of cytotoxic agents among most nursing and pharmacy OR staff members. These guidelines are meant to reduce the risk of errors from the administration of chemotherapy and can be applied to HIPEC.
Institutions performing HIPEC should have a written policy that outlines who can order, prepare, and administer HIPEC. This policy should describe the credentials of these individuals and how competency is demonstrated on a periodic basis. The policy should be written, reviewed, and approved by surgeons, oncologists, nurses, and pharmacists involved with HIPEC. It is important to recognize that existing chemotherapy policies may need to be amended if current policy restricts the ordering of chemotherapy to a specialty.
We recommend HIPEC be ordered through computerized provider order entry by using a standard electronic chemotherapy order set. Order set(s) should be literature based and validated by surgeons performing HIPEC. Prescribing chemotherapy outside established order sets should be discouraged. Commonly prescribed chemotherapy agents used in HIPEC and relevant clinical pearls are presented in Table 2.
|Peritoneal mesothelioma (single agent or with doxorubicin)
|50-100 mL to achieve final concentration of 0.05-2 mg/mL
|48 h RT
|Dilute in NS, D51/2NS, D5NS
|Gastric cancer (with mitomycin)
|Not stable in D5W
|Addition of sodium thiosulfate is used for renal protection
|Ovarian cancer (with paclitaxel)
|Do not use aluminum-containing IV sets
|50-100 mL to achieve final concentration of 0.5-4 mg/mL
|8 h RT
|Dilute in D5W or NS
|7 d RT, 14 d RF
|Dilute in NS
|Not stable in D5W
|Protect from light
|Mucinous ovarian tumors
|6 h RT, 24 h RF
|Dilute in D5W
|Not stable in NS
|Peritoneal mesothelioma (with cisplatin)
|48 h RT
|Dilute in NS or D5W
|Ovarian cancer (with paclitaxel or mitomycin)
|Desmoplastic round cell tumors
|Ovarian cancer (with cisplatin)
|50-100 mL to achieve concentration of 0.3-1.2 mg/mL
|27 h RT
|Dilute in NS or D5W
|Dispense in non–PVC-containing IV bags and tubing
|Premedication with steroid and antihistamine is not required for HIPEC
- Abbreviations: CBC, complete blood count; CMP, complete metabolic panel; D51/2NS, dextrose 5% and 0.45% normal saline; D5NS, dextrose 5% and normal saline; D5W, dextrose 5%; HIPEC, hyperthermic intraperitoneal chemotherapy; IV, intravenous; NS, normal saline; PVC, polyvinyl chloride; RF, refrigerated; RT, room temperature.
- a The data in this table were taken from references 14 and 15.
Communication between the team delivering intraoperative chemotherapy and the chemotherapy pharmacy team is critical. Issues with drug procurement or national shortages should be reported to the operative team per usual pharmacy procedures. It is essential to adequately communicate the timing, concentration, and volume of the intraoperative chemotherapy. This information is required to establish a sufficient quantity of chemotherapy to keep in stock to support the HIPEC program.
The HIPEC program should indicate to pharmacy staff the hours when chemotherapy may be ordered and the expected turnaround time for drug delivery. Ideally, chemotherapy should be ordered in advance to allow pharmacy staff adequate time to properly check dosing calculations, laboratory parameters, and supportive care and to allow for dedicated time to ensure safe and accurate drug preparation and verification.
Prior to chemotherapy administration, documentation confirming the name and dose of chemotherapy that will be used in HIPEC must be available in the electronic health record. Patient consent should be obtained, and a signed copy should be accessible to both pharmacy and nursing staff. Best-practice consent should include the names of the chemotherapy agents to be administered and a list of expected adverse effects at a minimum.
The order set should include the generic name of the chemotherapy, the dose per square meter or flat dose, the base bag volume, the base fluid, and the date of administration. The order should indicate the dosing frequency. Furthermore, the order should indicate the route of administration of chemotherapy, especially when it is being used as bidirectional chemotherapy (intravenous and intraperitoneal).
The pharmacy label should include at minimum the patient name, medical record number, generic name of chemotherapy, dose in appropriate units, volume and type of base fluid, frequency, route of administration, and time when medication is due. An auxiliary label signifying to staff that the drug product is classified as chemotherapy is also recommended. Supportive care typically ordered with systemic chemotherapy should be considered; however, note that the emetogenic and myelosuppressive effects of HIPEC are generally less. HIPEC orders should be verified via a dual check system by 2 licensed pharmacists and nurses trained and competent in chemotherapy preparation and administration.
Because of the large volume of fluid exchanged during surgery, the base bag volume for chemotherapy should be kept to a minimum. We suggest 50 to 100 mL total. Chemotherapy bags should be delivered at room temperature with tubing commensurate with needs established by the perfusion team.
Chemotherapy is considered an antineoplastic hazardous drug per the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) guidelines. Therefore, pharmacy staff should prepare HIPEC in a biologic class II safety cabinet with established primary and secondary controls to prevent exposure. Safeguards used to prepare HIPEC do not differ from those used to prepare parenteral chemotherapy. Personal protective equipment should be worn in the OR setting by the surgeons and nursing staff. Drugs should be dispensed using a closed-system transfer device meant to further diminish occupational exposure. Given the hazardous nature of chemotherapy, HIPEC-containing material should be disposed of in a hazardous waste container. This practice should be maintained in the postoperative period until most of the drug has been excreted (48 hours). Double gloving with latex gloves (or chemotherapy-safe nonlatex gloves) is recommended for the OR team. Personal protective equipment, including eye protection and chemotherapy-safe gloves, is essential for staff members who are not scrubbed in. Trace waste, such as that found in an empty chemotherapy bag and tubing, is disposed of in a chemotherapy-designated bin. Large-volume waste from the chemotherapy volume exchange should be disposed of in a black hazardous material container. Detailed spillage policies, along with an emergency procedure in case of a large-volume spill and exposure to the team, should be readily available and accessible to the staff.
The CDC NIOSH guidelines state that most chemotherapy is hazardous to both men and women actively trying to conceive, women who are pregnant or may become pregnant, and women who are breastfeeding because the drug may be present in breast milk.14 Therefore, these agents may present an inherent reproductive risk to health workers from occupational exposure. While the consistent and proper use of personal protective equipment minimizes the risk of occupational exposure during administration of HIPEC, the risk is not eliminated. Reproductive risk can include fetal loss, teratogenicity, and/or fertility impairment. The ASCO recently published the 2019 ASCO standards on the safe handling of hazardous drugs. To minimize the risk of occupational exposure to hazardous drugs, standard 5 of this document recommends that health care settings consider potential alternative duty options for workers who are actively trying to conceive, are pregnant, or are breastfeeding.15
Despite the inherent risks, with proper application of the procedures described herein, a safe, efficient, and effective HIPEC program can be implemented.
Standards of Imaging
High-quality cross-sectional imaging is essential in the appropriate management of patients with peritoneal surface malignancies. Preferred modalities of peritoneal imaging include multislice CT and contrast-enhanced MRI. Although ultrasound is used for dynamic imaging of ascites, it is not currently used as a primary modality for the diagnosis or surveillance of peritoneal disease. Expertise in interpretation of images with a specific focus on clinically relevant features (mesenteric foreshortening, involvement of the portal triad, inferior vena cava bursa, diaphragmatic involvement, multifocal bowel obstruction, involvement of the seminal vesicles, ureteral obstruction, etc) is recommended. Specific documentation of burden of disease to facilitate the calculation of an imaging PCI is recommended.
Patients with high-grade disease should receive systemic staging performed with standard accepted modalities. Patients with mucinous tumors are overrepresented among those who develop peritoneal metastases, and FDG18-PET scans may be less sensitive in this population. Preferred staging of the peritoneum includes multidetector contrast-enhanced CT scans or contrast-enhanced MRI. Peritoneal-specific protocols are heterogeneous but favor distension of the intestines with large-volume oral contrast material, use of rectal contrast material in patients with concern for pelvic disease, use of intravenous contrast material with delayed sequences, and use of diffusion-weighted imaging with b values of 500 to 1000 s/mm2. Appropriate distension of the intestine can help reveal periserosal tumors. In patients with chronic renal failure who are receiving dialysis, CT of the abdomen and pelvis with intravenous iodinated contrast material and oral contrast material can be used. In patients with chronic renal failure (glomerular filtration rate <30 mL/min) who are not receiving dialysis, intravenous gadolinium-based contrast agents can be administered in select cases using gadoterate meglumine (preferably) or hepatocellular agents such as gadoxetate disodium or gadobenate dimeglumine.
Funded by the Irving Harris Foundation and the University of Chicago.
Conflict of Interest Disclosures
James C. Cusack reports grants from Lumicell, Inc, outside the submitted work. Carla Harmath serves on the medical advisory council of Accumen. Hedy Kindler reports personal fees and nonfinancial support from Inventiva, AstraZeneca, Boehringer Ingelheim, Merck, and Paredox; personal fees from Aldeyra Therapeutics, Bayer, Bristol-Myers Squibb, Erytech, Five Prime Therapeutics, Ipsen Pharmaceuticals, Kyowa, and MedImmune; and funds to support clinical trials at her institution from Aduro, AstraZeneca, Bayer, Bristol-Myers Squibb, Deciphera, GlaxoSmithKline, Lilly, Merck, MedImmune, Polaris, Verastem, and Blueprint, all outside the submitted work. Garrett M. Nash reports nonfinancial support from Intuitive outside the submitted work. Aytekin Oto reports grants from Philips Healthcare, Guerbet, and Profound Healthcare and serves as a medical advisory board member for Profound Healthcare, all outside the submitted work. Nita Ahuja reports grant funding from Cepheid and Astex, has served as a consultant to Ethicon, and has licensed methylation biomarkers to Cepheid. Jesus Esquivel reports personal fees from Eight Medical. The other authors made no disclosures.