Tenckhoff tunneled peritoneal catheter placement in the palliative treatment of malignant ascites: technical results and overall clinical outcome

A retrospective analysis was carried out on consecutive patients in whom a Tenckhoff tunnelled peritoneal catheter was inserted percutaneously for the management of refractory malignant ascites in the authors’ institution between March 2006 and January 2013. The inclusion criteria for catheter placement were symptomatic, malignant ascites refractory to conservative and medical management in patients with widespread metastatic disease; haemostatic parameters allowing small skin incisions and subcutaneous tunnelling; absence of compartmentalization of the malignant ascitic fluid. Active infection is considered as an exclusion criterion for catheter insertion. Refractory malignant ascites is defined as ascites in patients with widespread metastatic disease in whom the ascites cannot be mobilized by conservative or medical therapies. Patients’ history, procedural and post-procedural data were documented based on the patients’ hospital electronic medical records and after telephone calls with the patients’ general practitioners.

The patients gave informed consent before the start of the interventional procedure and institutional review board approval was obtained for this retrospective study analysis.

Patients were referred to the interventional radiology department after discussion between the attending interventional radiologist and medical or surgical oncologist. Patient preparation included a bedside ultrasound for evaluation of the amount of ascites and more specifically for evaluation of a window of ascitic fluid at the intraperitoneal puncture site. The preferred intraperitoneal puncture site was near the midline, inferior and to the right of the umbilicus; if no ascitic fluid window was identified in that area, a left-sided infra-umbilical puncture site was prepared with a tunnel area to the left flank. Laboratory analysis included acceptable haematological parameters for tunneled catheter insertion, including a platelet count of at least 50,000/L, a haemoglobin level > 8 g/dL and an International Normalized Ratio (INR) of less than 1.5. Tenckhoff tunneled peritoneal drainage catheter insertion was performed under sterile conditions in the interventional radiology suite.

After standard surgical preparation, local anaesthesia of the puncture site and the subcutaneous tunnel area was administered with 30 mL of lidocaine hydrochloride (Linisol 2%, B. Braun, Diegem, Belgium). No other sedation or prophylactic antibiotic medication was administered; a 2 cm skin incision was made near the midline, inferior and to the right (or left) of the umbilicus and ultrasound-guided puncture of the malignant ascitic fluid was carried out using an 18 gauge (G) sheathed needle (Surflo I.V. Catheter, Terumo Europe, Leuven, Belgium) (Figure 1A). A 0.035 inch hydrophilic guide wire (HydroSteer, St-Jude Medical, St-Paul, MN, USA) was introduced into the peritoneal cavity using a 0.035 inch 4 French (F) Cobra catheter (Slip-cath, Cook Medical, Bjaeverskov, Denmark) positioned in the pelvis (Figure 1B). This was then exchanged for a 0.035 inch stiff guide wire (Amplatz, Cook Medical, Bjaeverskov, Denmark) (Figure 1C). Over the stiff guide wire the puncture tract was dilated using a 8F dilator (Cook Medical, Bjaeverskov, Denmark) and finally a 15F peel-away introducer (PTFE-peel-Apart, BARD Benelux, Olen, Belgium) was inserted (Figure 1D). The Tenckhoff peritoneal drainage catheter (Argyle peritoneal dialysis catheter, Covidien, Mansfield, MA, USA) with the Cobra catheter inside was introduced over the stiff guide wire into the peritoneal cavity and positioned in a curved position in the lower pelvic region (Figure 1E). The Tenckhoff catheter is made of translucent silicone rubber tubing containing a radio-opaque stripe. The total length of the 15F catheter is 47 cm and the inner diameter is 2.6 mm. The intraperitoneal part of the catheter contains small fenestrations over a length of 15 cm (Figure 2). The cuffed end of the Tenckhoff catheter is tunnelled to the right (or left) flank using a metallic tunnelling device (Argyle Faller Tunneling device, Covidien, Mansfield, MA, USA) and exteriorized 7 cm lateral to the peritoneal entry site. Finally, the small cutaneous incisions are sutured and the external part of the tunnelled catheter is connected to a drainage bag (3L Empty Bag System II, Baxter Healthcare, Zurich, Switzerland) using a sterile connecting device (Connection Shield System II with Povidone-Iodine Solution, Baxter Healthcare, Zurich, Switzerland) to begin drainage.

The intraperitoneal chemotherapy infusion technique was performed using a catumaxomab-based regimen as described by Baumann et al.¹⁴ Briefly, catumaxomab (Removab^®, Neovii Biotech, Waltham, MA, USA) 10 μg, 20 μg, 50 μg and 150 μg in 250 mL of 0.9% NaCl physiologic solution was injected intraperitoneally through the Tenckhoff catheter, respectively at day 1, 4, 8 and 11 of the treatment.

Patients were followed up until the end of the study (March 2013) or the patient's death.

Overall survival probabilities are estimated by the Kaplan-Meier method. The Wilcoxon test is used for testing survival differences between ovarian cancer patients with or without intraperitoneal chemotherapy treatment (IPCT). The prognostic value of primary pathology for survival is analysed using Cox proportional hazards models. Fisher's exact test is used for the association between intraperitoneal chemotherapy treatment and catheter infection.

All tests are two-sided. A 5% significance level is assumed for all tests. All analyses have been carried out using SAS software, version 9.3 of the SAS System for Windows (SAS Institute Inc., Cary, NC, USA).

In 94 patients (27 men; 28.7% and 67 women; 71.3%) with a mean age of 60.1 years (median 59.4 years; standard deviation 12.4 years) a tunnelled peritoneal Tenckhoff catheter was inserted for drainage of malignant ascites. Malignant ascites was associated with different types of metastatic cancer disease as summarized in Table 1. The category ‘rest’ included lung carcinoma (n = 2), multiple myeloma (n = 2) and myxoid liposarcoma (n = 1).

The number of paracenteses prior to Tenckhoff catheter insertion is indicated in Table 2; overall, patients underwent a mean of 3.4 paracenteses (median: 2.0; standard deviation: 5.6; range: 0–44 paracenteses). In 15 out of 94 patients (16%) intraperitoneal chemotherapy treatment (IPCT) with catumaxomab was given; these 15 patients suffered from widespread metastatic ovarian cancer associated with refractory malignant ascites.

In all patients (100%), the Tenckhoff tunnelled peritoneal drainage catheter was successfully inserted; in 90 patients (96%), the Tenckhoff catheter was tunnelled subcutaneously into the right flank, in the remaining 4 patients (4%) the peritoneal access was made in the left para and infraumbilical region and the catheter was tunnelled into the left flank. Once the Tenckhoff catheter was in place, a median of 3,260 cc (range 100 cc – 8,500 cc) of malignant ascitic fluid was drained.

Clinical follow-up was available for 90 patients; 4 patients (4.2%) were lost to follow-up.

Two patients (2.1%) presented with a clinical suspicion of catheter infection, including fever, painful cutaneous and subcutaneous tunnel infection, but without clear signs of peritonitis, 36 & 40 days respectively after initial catheter placement. One of these two patients was also treated with intraperitoneal chemotherapy infusions. Other minor complications included ascitic fluid leakage around the entry point of the catheter in the right flank (n = 4; 4%), catheter occlusion (n = 2; 2%) and sleeve formation around the tip of the catheter resulting in insufficient drainage (n = 1; 1%). Management of these complications included extra skin sutures around the catheter entry point (n = 4), catheter removal (n = 1) or catheter flushing (n = 2) respectively.

In another three patients (3%), initially presenting with malignant ascites related to breast carcinoma (n = 1), endometrial carcinoma (n = 1) and ovarian carcinoma (n = 1), the Tenckhoff catheter was removed after 111, 134 and 39 days respectively, owing to regression of ascitic fluid production. Another patient accidentally lost the catheter 11 days after initial placement.

Five out of 90 patients (5.3%) were still alive at the end of the study (March 2013); the remaining 85 patients (90.4%) died before March 2013. The time interval until end of follow-up or the patient's death was a mean of 3.41 months (median 1.7 months; standard deviation: 4.73; min: 0.03, max 25.7 months).

Kaplan-Meier estimates for overall survival after Tenckhoff insertion is summarized in Figure 3 and Table 3, showing an estimated survival at 3 and 6 months of nearly 30% and 18% respectively. Further, a more detailed analysis of survival after Tenckhoff catheter insertion is made based on the underlying type of cancer. We analysed five categories of underlying aetiologies: gynaecological cancers (n = 40) including ovarian and endometrial cancers; hepatobiliary cancers (n = 22) including pancreatic cancer, cholangiocarcinoma and hepatocellular carcinoma; gastrointestinal cancers (n = 11) including colorectal cancer, gastric cancer and neuroendocrine tumours; breast carcinoma (n = 11) and rest (n = 5) including lung carcinoma (n = 2), multiple myeloma (n = 2) and myxoid liposarcoma (n = 1); the survival of these different groups is summarized in Figure 4. Analysis suggests a difference in risk for early death after Tenckhoff catheter insertion according to the underlying cancer: patients with widespread gastrointestinal cancers and refractory malignant ascites have a higher risk for early death compared to the reference group of patients with widespread metastatic gynaecological cancers.

Overall survival after clinical diagnosis of malignant ascites demonstrates a 3 and 6 month estimated survival of 82.0% and 63.9% respectively, as shown in Table 4 and Figure 5. An analysis of the potential outcome differences between the five categories of cancer mentioned above was carried out and summarized in Table 5 and Figure 6. The risk analysis for early death after clinical diagnosis of malignant ascites also demonstrates a significant difference in survival for patients with malignant gynaecological cancer compared to patients with gastrointestinal cancers (p = 0.007).

Tunnelled Tenckhoff catheters were inserted in a total of 38 patients presenting with metastatic ovarian cancer and malignant ascites. In 23 of these patients the Tenckhoff catheter was inserted solely for repeated drainage purposes. In the remaining 15 patients the Tenckhoff catheter was inserted for the purpose of drainage of malignant ascites and for the purpose of intraperitoneal infusion of a catumaxomab-based solution. Overall survival of the two sub-groups of patients (Table 6 and Figure 7) revealed better survival in the group with intraperitoneal infusion of catumaxomab (p = 0.02).