Abstract
Abstract
Background and Objective:
Ascites complicates many advanced malignancies, resulting in abdominal pain, discomfort, anorexia, nausea, and dyspnea. Percutaneous drainage relieves symptoms in the vast majority of patients. The aim of this study was to determine the course and outcomes in a consecutive series of patients with recurrent ascites managed with permanent peritoneal ports.
Methods:
A prospective longitudinal descriptive study from 2006 to 2011, involving patients treated at the Sydney Cancer Center (New South Wales, Australia).
Results and Conclusions:
A total of 155 drainages were performed in 24 patients; 26% of drainages (n=40) in the patient's home and the remainder in the ambulatory care clinic. Grade 3 or higher adverse events occured in less than 25% of all draining procedures. An improvement in symptoms was demonstrated in almost half of all individual drainage procedures. Our findings suggest that peritoneal ports are efficacious, safe, and are associated with symptomatic relief in most patients.
Introduction
Methods
A prospective longitudinal descriptive study from 2006 to 2011was conducted, involving patients treated at the Sydney Cancer Center (New South Wales, Australia) and approved by the local human research ethics board. Eligibility criteria included patients with peritoneal ports (titanium peritoneal ports with fenestrated polyurethane catheters) inserted for the sole purpose of regular ascitic drainage to relieve symptomatic malignant ascites. Patients were approached prior to port insertion, and were formally enrolled once the procedure had taken place. Follow-up was conducted at each planned and unplanned visit to the cancer center.
Peritoneal ports were inserted by interventional radiologists and were accessed by accredited nursing staff members who had undergone specific training.
Medical and demographic data were obtained from the patients' medical record. Before and after each drainage episode, patients were asked to complete an eight-item Edmonton Symptom Assessment Scale (ESAS), a validated tool using a numerical analogue score (0=no symptoms, 10=worse possible symptoms), 5 and to rate the following symptoms: pain, tiredness, drowsiness, shortness of breath, lack of appetite, depression, anxiety, and well-being. Procedure-specific toxicities were graded according to the Common Terminology Criteria for Adverse Events version 4.0.
Results
Twenty-four patients were recruited with a median age of 61 (range 18–84). Most patients had an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3. Colorectal, ovarian, and breast cancer accounted for more than half of the underlying malignancies (Table 1).
ECOG, Eastern Cooperative Oncology Group; HCC, hepatocellular carcinoma.
All patients had previously received chemotherapy. Peritoneal ports remained in situ for a median of 53 days (range 12–1149 days), and all ports were still functioning at the time of death. One port required replacement for occlusion.
A total of 155 drainages were performed in the 24 patients; 26% were performed (n=40) in the patient's home and the remainder in the ambulatory care clinic. The mean number of drainages per patient was 6.5 (range 1–21). The mean volume of ascites removed per paracentesis was 4200 mL (interquartile range 3195 mL).
The majority of drainages were completed without any serious adverse events; 75% of adverse events were less than grade 3. The most frequent adverse event was grade 2 hypoalbuminemia (Table 2). One patient required admission to the hospital for intravenous fluid therapy after developing hypotension (grade 3), hyponatremia (grade 3) and renal impairment (grade 2). Another patient developed cellulitis adjacent to the port site (grade 3) that resolved with intravenous antibiotics.
AE, adverse event.
Of a total of 156 drainage episodes, 110 complete ESAS questionnaires were completed. In 25% to 47% of cases, a single drainage improved at least one symptom by 2 or more points on the ESAS. Although benefit was documented in all symptoms, pain and breathlessness were relieved most frequently (42% and 47%, respectively). Throughout the entire duration of the study, most patients experienced immediate symptomatic benefit following at least one drainage procedure (Table 3).
Symptoms were self-rated on a scale from 0 to 10, before and after port access and subsequent ascitic drainage.
Discussion
This study suggests that subcutaneous peritoneal port placement is safe, feasible, and results in symptomatic improvement for most patients.
Ports were inserted late in the disease trajectory in patients who were heavily pretreated with chemotherapy. Infection (cellulitis) occurred in only one patient and was easily treated. There were no episodes of peritonitis. In the literature, the incidence of significant infections, particularly peritonitis, appears to be higher with the use of indwelling peritoneal catheters (a permanent external catheter, penetrating the skin and entering the peritoneum) and peritonitis rates ranging from 11% to 35% have been described.6,7 Very few cases of peritonitis associated with peritoneal ports have been described4,8; uncomplicated cellulitis has been suggested as the most common infectious complication, occurring in 18% in one series. 9
Hypotension, consistent with other series, was not significant in our study. Indwelling catheters, in contrast, have been associated with individual cases of fatal hypotension in the immediate postinsertion period. 7 The one patient in our cohort who suffered from grade 3 hypotension had 9.3 L of ascites drained on that occasion and therefore the complications were likely secondary to excessive ascitic removal and not directly because of the peritoneal port. Hypoalbuminemia, the most common adverse effect in our study, was most likely influenced by disease progression and was therefore not entirely attributable to ascitic drainage.
In all of our cases, the ports remained in situ until death, and the number of “port days” was determined by the patients' survival times rather than the durability of the ports. Peritoneal ports remained in situ for a median of 8 weeks (range 2 weeks–3 years). This is comparable to other reported series with median port days ranging from 5 to 10 weeks. 4
An improvement in symptoms was demonstrated in almost half of all individual drainage procedures. Seventy-five percent of patients experienced benefit in at least one symptom at some point during the study, particularly with respect to pain and breathlessness. To our knowledge, no other validated symptom assessment exists in this setting.
The fact that 36% of drainage episodes were performed in the ambulatory setting implies cost and convenience benefits above standard paracentesis.
The ideal time to insert a peritoneal port remains difficult to determine as clinicians are reluctant to subject dying patients to invasive procedures. Although this question is not directly answered by our study, all ports remained active up until death (median 53 days), suggesting that earlier insertion is likely to be safe and efficacious.
Our study has a number of limitations. More than 40 ESAS questionnaires were not completed. Although the reasons were not determined in this study, patient inconvenience, language barriers, and the large number of drainages that were performed in the community appeared to be largely responsible. The relief experienced by patients in this study was directly related to the removal of ascitic fluid and hence the incremental symptomatic benefit of a peritoneal port over standard paracentesis remains difficult to determine. The small cohort size limits the strength of our findings; however, it is comparable to that of related studies in the literature. All nursing staff members involved in accessing the ports required specific training beforehand, and furthermore undergo annual reassessment. The cost associated with this education is not incorporated into our study.
The prospective data collection of our study is a significant strength. The combination of efficacy, safety, and symptom assessment data is unique and provides a broad overview of the utility of peritoneal ports. Although the patient numbers are few, a large number of completed ESAS questionnaires were completed, providing strength to that component of the study.
Our findings suggest that peritoneal ports are efficacious, potentially safe, and are associated with symptomatic relief in most patients. Further studies, with safety, convenience, quality-of-life, and cost-benefit comparisons with standard paracentesis are required to place peritoneal ports as the preferred option for the symptomatic treatment of malignant ascites.
Author Disclosure Statement
No competing financial interests exist.
