Interventions

There are two LTADs currently available in the UK: the PleurX™ (UK Medical Ltd., Basingstoke, UK [24]) and the Rocket® (Rocket Medical, Watford, UK [25]). We have chosen to use the Rocket device (Fig. 1) [25] primarily because our local clinicians and community nursing teams are already familiar with it. Rocket Medical already has an established training and support programme for local community nurses and care homes. In addition, our earlier experience [26] suggests that the Rocket devices are easier to insert than the PleurX™ devices and that they require less expensive consumables that can currently be prescribed by community practitioners.

Rocket Medical Long-Term Abdominal Drain in situ [25]

Insertion of the LTAD will be performed in hospital in a side room, using bedside ultrasound guidance. Insertion will only be performed if, within the week leading up to planned LTAD insertion, haemostatic function (including INR and platelet count) has been checked and blood products administered as necessary. Where INR is > 1.7, patients will receive up to two volumes of fresh frozen plasma (FFP), transfused according to patient weight and INR, immediately prior to drain insertion. Where the platelet count is ≤ 50 × 10⁹, patients will be given one to two pools of platelets immediately prior to insertion of the drain.

To ensure consistency, it would be ideal that all LTADs are inserted at one site (RSCH), but if this is not possible due to patient preference or logistic issues, they will be inserted at local sites, usually by an interventional radiologist.

The Rocket® LTAD will be inserted using a combination of tunnelled and Seldinger technique as stated in the Rocket® information sheet [25]. After confirming the location of the insertion site using bedside ultrasound and skin preparation with Chloraprep™ (chlorhexidine gluconate and isopropyl alcohol), a local anaesthetic (up to 10 ml 1% or 2% lidocaine) will be administered at the incision site and along the proposed tunnel tract. A small incision is made where the catheter will enter the abdominal cavity. The introducer needle will be inserted through the incision into the peritoneal cavity and a guide wire is passed through the needle, which will then be removed. A second incision (exit site) will be made approximately 5 cm medial from the first, where the catheter will exit the tunnel. The catheter will be tunnelled from exit site incision to the first incision site with the tunneller, making sure that the cuff is midway between the first and second incision sites. A split-sheath dilator will then be passed over the guide wire, and the inner dilator and guide wire removed, leaving the split sheath in situ.

The tunneller is then removed from the catheter, which is then passed through the split sheath, separating the split sheath and ensuring that all of the catheter is contained within the peritoneum. The last piece of the split sheath is then removed. The catheter is then adjusted along the tunnel, so the cuff moves towards the exit site, ensuring that any kinks are removed from the catheter. Finally, both incision sites will be sutured (avoiding the catheter) and a dressing applied.

Participants will receive antibiotic prophylaxis (ciprofloxacin 500 mg/day) or an equivalent antibiotic (if there is a contraindication to ciprofloxacin), dependent on local practice.

We will provide guidance to the participant and carer (where present) on how to use the LTAD, based on the information previously supplied in the PIS. Participants will also be given an information sheet provided by Rocket Medical [25]. Participants will be referred to their community nursing service. A Rocket Medical discharge letter will be sent to their GPs and the community nursing team. Rocket Medical will also be informed so that they can organise any further support/training for patients, carers and community nurses. In addition, we will arrange for drainage bags to be delivered directly to the participant’s usual place of residence on request by the community nurses.

The community nurses will visit the participants in their homes and either perform the drainage procedure themselves or supervise the drainage of ascites. The frequency of these visits will depend on the participant’s ascites-related symptoms, but work in ascites due to malignancy [12, 27] indicates that two to three visits each week are most commonly required, with approximately 1–2 L of ascites being drained each time. It is recommended that the drainage frequency not exceed three times per week. In the event that participants and/or carers wish to perform self-drainage, they will be trained to do so by the community nurse.

The Integrated Primary Care Team (IPCT) will closely monitor trial participants allocated to the LTAD arm. We expect that this will happen two to three times a week if the community nurses are performing ascitic fluid drainage.

For participants who live in a care home or move to a care home (with or without nursing), the follow-up procedure would be the same as for patients who live at home. In such cases we would seek approval from the care home managers. For those requiring hospice care, this would be a temporary stay, since hospices do not generally provide long-term care. Again, permission will be sought from the hospice team to visit the participants for follow-up and only if such visits remain acceptable to the participants.

Participants randomised to LVP [3], the current standard of care, will be admitted to hospital as either a self-referral or via their GP, whichever is current local practice. They will undergo LVP as clinically indicated. LVP involves the insertion of a peritoneal drain for up to 6 h and removal of up to 15 L of ascites. If the total volume of fluid to be removed is > 5 L, intravenous 4.5% or 20% (w/v) human albumin solution, 8–10 g per 1 L of ascitic fluid removed, will be administered [3].

As with Group 1, participants will receive antibiotic prophylaxis (ciprofloxacin 500 mg once a day or an equivalent antibiotic (if there is any contraindication to ciprofloxacin), dependent on local practice).

For both groups there will be two weekly visits with a research team member for questionnaire-based and clinical assessments as well as routine clinical blood samples (as discussed in subsequent sections). We anticipate that these two weekly contacts will improve adherence to the protocol.