AscitesROLLONNCT04232384
Comparison of "Roll-over' Technique With Standard Abdominal Paracentesis in Suspected Peritoneal Carcinomatosis
A study testing Standard Paracentesis and Roll Over Paracentesis in people with Ascites and Peritoneal Carcinomatosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ascites, Peritoneal Carcinomatosis, Peritoneum Neoplasm
- What is being tested?
- Standard Paracentesis and Roll Over Paracentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jun 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
About this study
Official title: A Randomized Study of "Roll-over' Technique With Standard Abdominal Paracentesis to Improve Cytological Yield in Patients Suspected to Have Peritoneal Carcinomatosis
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.
Read the detailed description
Trial Design
The study will be a randomized comparison between two methods of abdominal paracentesis with a cross-over design and each participant will also serve as a control (standard paracentesis).
Participants
The study will be done on the patients who will visit Outpatient departments or admitted as an inpatient in the Post Graduate Institute of Medical Education and Research, Chandigarh.
Screening population: All patients with ascites
Assessment of study population:
Patients fulfilling inclusion and exclusion criteria as per screening will be subjected to baseline investigation in the form of hemogram, biochemistries, coagulogram, ascitic fluid evaluation as per predesigned proforma. All patients in the study group will be subjected to imaging and an attempt will be made to establish the primary site of malignancy based on histopathology.
Patients fulfilling inclusion and exclusion criteria will undergo randomization into two groups. One group will be the standard paracentesis group (SPG) and the other will be the rollover group (ROG). Randomization will be done using an opaque sealed envelope.
Patients fulfilling inclusion and exclusion criteria will undergo abdominal paracentesis twice in one of the following ways.
Standard paracentesis group (SPG):
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).
Rollover group (ROG):
Patients with ascites will be rolled over thrice in bed laterally up to 90 degrees on either side and the 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 and so on to complete three complete 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.
Details of ascitic paracentesis
The patient will undergo abdominal paracentesis twice in the order as allocated randomly. The patients will be asked to empty his bladder prior to the procedure. The anterior abdominal wall will be cleaned with a Povidone-iodine solution followed by isopropyl alcohol/ chlorhexidine. The site of the paracentesis will be the peritoneal space in the left lower quadrant between the umbilicus and the anterior superior iliac spine or the patient's flank, depending on the location of the fluid as determined by percussion of the fluid wave. Alternatively, in midline 3 to 4 cm below the umbilicus, halfway between the symphysis pubis and the umbilicus. On both occasions, 20 ml of the ascitic sample will be collected in clean dry containers with appropriate labeling of name and hospital registration number. 20 ml of the sample obtained on each of these occasions will be sent for cytological analysis. To ensure that both the groups are treated similarly the paracentesis will be done using a 20 ml syringe using 21 Gauge 1 1/2" hypodermic needle. It will be ensured to avoid old surgical scars since the bowel may be adherent to the abdominal wall. The site of the paracentesis will be closed with tincture benzoin. The ascitic fluid sample for malignant cytology will be transported to the laboratory within one hour of paracentesis.
- Being tested
- Standard Paracentesis, Roll Over Paracentesis
- Medical subject headings
- Ascites, Peritoneal Neoplasms, Peritonitis, Tuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ParacentesisProcedure or surgery
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).
Roll Over ParacentesisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Roll Over Paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield of malignant cells
Number of samples reported positive for malignant cells out of the cases of peritoneal carcinomatosis
Measured: One month
Secondary outcomes (1)
Cellularity of the smear of the smear
Comparison of tumour cellularity, mesothelial cells and inflammatory cells between the two samples will be compared with each other to determine which of the smear had a better cellularity
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start15 Jun 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Recruitment slow due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Sharma, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Vishal Sharma, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232384
- Sponsor's protocol ID
- NK/6111/DM/055
- Acronym
- ROLLON
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34156308Jha 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.
PubMed 36795510
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of "Roll-over' Technique With Standard Abdominal Paracentesis to Improve Cytological Yield in Patients Suspected to Have Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT04232384
- Acronym / sponsor ID
- ROLLON / NK/6111/DM/055
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment slow due to COVID-19
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trial Design
The study will be a randomized comparison between two methods of abdominal paracentesis with a cross-over design and each participant will also serve as a control (standard paracentesis).
Participants
The study will be done on the patients who will visit Outpatient departments or admitted as an inpatient in the Post Graduate Institute of Medical Education and Research, Chandigarh.
Screening population: All patients with ascites
Assessment of study population:
Patients fulfilling inclusion and exclusion criteria as per screening will be subjected to baseline investigation in the form of hemogram, biochemistries, coagulogram, ascitic fluid evaluation as per predesigned proforma. All patients in the study group will be subjected to imaging and an attempt will be made to establish the primary site of malignancy based on histopathology.
Patients fulfilling inclusion and exclusion criteria will undergo randomization into two groups. One group will be the standard paracentesis group (SPG) and the other will be the rollover group (ROG). Randomization will be done using an opaque sealed envelope.
Patients fulfilling inclusion and exclusion criteria will undergo abdominal paracentesis twice in one of the following ways.
Standard paracentesis group (SPG):
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).
Rollover group (ROG):
Patients with ascites will be rolled over thrice in bed laterally up to 90 degrees on either side and the 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 and so on to complete three complete 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.
Details of ascitic paracentesis
The patient will undergo abdominal paracentesis twice in the order as allocated randomly. The patients will be asked to empty his bladder prior to the procedure. The anterior abdominal wall will be cleaned with a Povidone-iodine solution followed by isopropyl alcohol/ chlorhexidine. The site of the paracentesis will be the peritoneal space in the left lower quadrant between the umbilicus and the anterior superior iliac spine or the patient's flank, depending on the location of the fluid as determined by percussion of the fluid wave. Alternatively, in midline 3 to 4 cm below the umbilicus, halfway between the symphysis pubis and the umbilicus. On both occasions, 20 ml of the ascitic sample will be collected in clean dry containers with appropriate labeling of name and hospital registration number. 20 ml of the sample obtained on each of these occasions will be sent for cytological analysis. To ensure that both the groups are treated similarly the paracentesis will be done using a 20 ml syringe using 21 Gauge 1 1/2" hypodermic needle. It will be ensured to avoid old surgical scars since the bowel may be adherent to the abdominal wall. The site of the paracentesis will be closed with tincture benzoin. The ascitic fluid sample for malignant cytology will be transported to the laboratory within one hour of paracentesis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard paracentesis group (SPG) | Active comparator | Procedure: Standard ParacentesisThe 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). |
| Rollover paracentesis group (ROG) | Experimental | Procedure: Roll Over ParacentesisPatients 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ParacentesisThe 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 or surgery | Standard paracentesis group (SPG) |
| Roll Over ParacentesisPatients 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 or surgery | Rollover paracentesis group (ROG) |
Primary outcome
Yield of malignant cells
Time frame: One month
Number of samples reported positive for malignant cells out of the cases of peritoneal carcinomatosis
1 secondary outcome
Cellularity of the smear of the smear
Time frame: One day
Results and safety
The study was stopped early (reason given: Recruitment slow due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 34156308Sharma 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.
- Derived from this study: PubMed 36795510Jha 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.
- Individual participant dataSharing planned: No
Related trials for Ascites
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
Enrolling by invitationPhase 4
Low Dose Versus Standard Dose Albumin
Decompensated Cirrhosis and Ascites
RecruitingPhase 1/2
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
STOMACH NEOPLASM, Gastric Cancer
RecruitingPhase 2
High Dose Albumin in Refractory Ascites
Ascites
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishal Sharma, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Paracentesis and Roll Over Paracentesis in people with Ascites and Peritoneal Carcinomatosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment slow due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield of malignant cells (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04232384, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.