Comparison of "Roll-over' Technique With Standard Abdominal Paracentesis in Suspected Peritoneal Carcinomatosis

NCT04232384 | Terminated

• 1 other identifier: NK/6111/DM/055
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ascites; Peritoneal Carcinomatosis; Peritoneum Neoplasm; Tuberculous Peritonitis

Outcome Measures

Primary Outcomes (1)

• Yield of malignant cells

  Number of samples reported positive for malignant cells out of the cases of peritoneal carcinomatosis

  One month

Secondary Outcomes (1)

• Cellularity of the smear of the smear

  One day

Study Arms (2)

Standard paracentesis group (SPG)

ACTIVE COMPARATOR

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).

Procedure: Standard Paracentesis

Rollover paracentesis group (ROG)

EXPERIMENTAL

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.

Procedure: Roll Over Paracentesis

Interventions

Standard Paracentesis PROCEDURE

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).

Standard paracentesis group (SPG)

Roll Over Paracentesis PROCEDURE

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.

Rollover paracentesis group (ROG)

Eligibility Criteria

• Age: 12 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (2)

• Sharma 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 BACKGROUND

• Jha 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 DERIVED

MeSH Terms

Conditions

Ascites; Peritoneal Neoplasms; Peritonitis, Tuberculous

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Tuberculosis, Extrapulmonary; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Peritonitis; Intraabdominal Infections

Study Officials

• Vishal Sharma, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: June 15, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)