Peritoneal Carcinomatosis Clinical Trial
— ROLLONOfficial title:
A Randomized Study of "Roll-over' Technique With Standard Abdominal Paracentesis to Improve Cytological Yield in Patients Suspected to Have Peritoneal Carcinomatosis
Verified date | March 2022 |
Source | Postgraduate Institute of Medical Education and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 71 |
Est. completion date | July 1, 2021 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Postgraduate Institute of Medical Education and Research | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Yield of malignant cells | Number of samples reported positive for malignant cells out of the cases of peritoneal carcinomatosis | One month | |
Secondary | 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 | One day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04826432 -
Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis
|
Phase 2 | |
Recruiting |
NCT03127774 -
Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma
|
Phase 2 | |
Recruiting |
NCT04024917 -
Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
|
N/A | |
Active, not recruiting |
NCT03508570 -
Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
|
Phase 1 | |
Not yet recruiting |
NCT04352894 -
Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection
|
N/A | |
Completed |
NCT05547568 -
A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring?
|
||
Completed |
NCT06318793 -
Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis
|
||
Terminated |
NCT01683864 -
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT04547725 -
Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis
|
N/A | |
Completed |
NCT03304210 -
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
|
Phase 1 | |
Withdrawn |
NCT03682744 -
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
|
Phase 1 | |
Terminated |
NCT04047771 -
A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis
|
Phase 1 | |
Recruiting |
NCT05623787 -
Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms
|
N/A | |
Recruiting |
NCT05063019 -
Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
|
N/A | |
Completed |
NCT02891447 -
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
|
Phase 2 | |
Recruiting |
NCT04231175 -
Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer
|
N/A | |
Not yet recruiting |
NCT04734691 -
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study
|
Phase 2 | |
Recruiting |
NCT04108936 -
Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
|
||
Completed |
NCT02604784 -
Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT01764789 -
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
|
N/A |