Randomized crossover trial of ‘Roll-over’ technique of abdominal paracentesis versus standard technique in suspected malignant ascites

ABSTRACT

Background

The sensitivity of single abdominal paracentesis for diagnosis of peritoneal carcinomatosis (PC) varies from 40–70%. We hypothesized that rolling-over the patient before paracentesis might improve the cytological yield.

Research design and methods

This was a single center pilot study with a randomized cross-over design. We compared the cytological yield of fluid obtained by roll-over technique (ROG) with standard paracentesis (SPG) in suspected PC. In the ROG group, patients were rolled side-to-side thrice, and the paracentesis was done within 1 minute. Each patient served as their own control, and the outcome assessor (cytopathologist) was blinded. The primary objective was to compare the tumor cell positivity between SPG and ROG groups.

Results

Of 71 patients, 62 were analyzed. Of 53 patients with malignancy-related ascites, 39 had PC. Most of the tumor cells were adenocarcinoma (30, 94%) with one patient each having suspicious cytology and one having lymphoma. The sensitivity for diagnosis of PC was (31/39) 79.49% in SPG group and (32/39) 82.05% in ROG group (p = 1.00). The cellularity was similar between both the groups (good cellularity in 58% of SPG and 60% of ROG, p = 1.00)

Conclusions

Rollover paracentesis did not improve the cytological yield of abdominal paracentesis.

Trial registration

CTRI/2020/06/025887 and NCT04232384

KEYWORDS:

• Malignant ascites
• tuberculous peritonitis
• peritoneal neoplasm
• peritoneal tuberculosis
• laparoscopy

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Availability of data and materials

The de-anonymised data will be provided by the corresponding author on a reasonable request

Ethics approval and consent to participate

The study was approved by the institutional ethics committee (Vide number INT/IEC/2020/SPL-679 dated 30/5/2020). Written informed consent was obtained from the participants prior to inclusion.

Additional information

Funding

This paper was not funded.