Clinical trial · Interventional
Comparison of "Roll-over' Technique With Standard Abdominal Paracentesis in Suspected Peritoneal Carcinomatosis
A Randomized Study of "Roll-over' Technique With Standard Abdominal Paracentesis to Improve Cytological Yield in Patients Suspected to Have Peritoneal Carcinomatosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment slow due to COVID-19
Summary
Brief summary (as posted)
The study will be a randomized trial that will compare two techniques of abdominal paracentesis in patients with suspected peritoneal carcinomatosis. The patients will undergo abdominal paracentesis by the standard technique and a rollover technique. In the standard technique, the patients will lie flat for 10 minutes and abdominal paracentesis will be taken for ascitic fluid cytology. In the rollover group, patients with suspected peritoneal carcinomatosis will be rolled over thrice laterally on each side by 90 degrees and sample will then be obtained for ascitic fluid cytology. both the samples will be processed by blinded cytopathologist for tumour cellularity and diagnostic yield.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ascites | — | UNRESOLVED | — |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Peritoneum Neoplasm | — | UNRESOLVED | — |
| Tuberculous Peritonitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Roll Over Paracentesis | Procedure | — | UNRESOLVED |
| Standard Paracentesis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard paracentesis group (SPG)
- description
- The patients will be asked to lie supine for 10 minutes and no changes in posture will be allowed for this period. Abdominal paracentesis will be done either by blind technique (in case the ascites is clinically detectable) or ultrasonography-guided (in cases the ascites is not clinically detectable).
- interventionNames
- Procedure: Standard Paracentesis
- type
- EXPERIMENTAL
- label
- Rollover paracentesis group (ROG)
- description
- Patients with ascites will be rolled over thrice in bed laterally upto 90 degrees on either side (Figure 1) and ascitic fluid sample is drawn within 1 minute of the last rollover. There will be four steps to this i.e roll over to one side at 90 degrees and then 180 degrees to the other side, then back to the first side and then back to the center (to complete three turns). This will be done after the disinfection and cleaning of the anterior abdominal wall have been done and the personnel involved in the procedure are ready for the paracentesis. The ascitic paracentesis will be initiated within one minute of the completion of the turn. One assistant will maintain a stopwatch during this period to ensure compliance with this.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: Patient with ascites where a diagnosis of peritoneal carcinomatosis is being considered on the basis of one or more of the following * Clinical Suspicion of peritoneal carcinomatosis on basis of a history of malignancy, painful ascites and/or loss of weight * Clinical Suspicion of peritoneal carcinomatosis on the basis of presence of ascites with lump or other stigmata of malignancy * Suspicion of peritoneal carcinomatosis on imaging suggestive of peritoneal carcinomatosis Exclusion Criteria: * Age \< 12 years * Refusal to participate or provide consent * Evidence of chronic liver disease-related ascites (evidence of cirrhosis on ultrasonography or evidence of portal hypertension eg varices on endoscopy) * Already diagnosed alternate cause of ascites like cirrhosis, pancreatitis, right heart failure - * Contraindications to paracentesis in the form of disseminated intravascular coagulation or local site infection.
References
Publications (2)
- BACKGROUNDSharma V, Jha DK, Rohilla M, Das CK, Singh H, Irrinki S, Arora A, Saha SC, Gupta P, Mandavdhare HS, Dutta U, Sharma A. 'Rollover' abdominal paracentesis versus standard technique: protocol of a crossover randomized comparative trial. Future Oncol. 2021 Sep;17(26):3425-3431. doi: 10.2217/fon-2020-1050. Epub 2021 Jun 22. PMID 34156308
- DERIVEDJha DK, Rohilla M, Das CK, Irrinki S, Singh H, Arora A, Saha SC, Gupta P, Mandavdhare HS, Dutta U, Sharma A, Sharma V. Randomized crossover trial of 'Roll-over' technique of abdominal paracentesis versus standard technique in suspected malignant ascites. Expert Rev Gastroenterol Hepatol. 2023 Mar;17(3):295-300. doi: 10.1080/17474124.2023.2181785. Epub 2023 Feb 21. PMID 36795510