Colorectal CancerNCT02754115
An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
An observational study of Colorectal Cancer and Ovarian Cancer, run by Tata Memorial Centre at 1 site in India.
Trial summary
Peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer, Ovarian Cancer, Peritoneal Disease
- What is being tested?
- Hyperthermic intraperitoneal chemotherapy
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2016to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: American Society of Anesthesiologist class I, II and III patients
Who may be able to join
- Age between 18 to 70 years
- ASA Class I to III
- Colorectal and gynecological oncology cases posted for CRS with HIPC.
Who cannot join
- Age less than 18 and more than 70 years
- ASA Class IV and above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Sohan L solanki, MD, 9869253201, me_sohans@yahoo.co.in
About this study
Official title: A Prospective Audit of Perioperative Parameters of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)
Peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C) and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all microscopic metastasis.
CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC phase, and even in the early postoperative period, with resultant significant morbidity and mortality. Despite that most of the reported patients are in American Society of Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team of anesthesiologist, surgeons and intensivist and other ancillary services can result in good outcome. This study will see the challenges faced by the team regarding the pathophysiological alterations during the CRS with HIPEC in the perioperative period.
- Conditions
- Colorectal Cancer, Ovarian Cancer, Peritoneal Disease
- Being tested
- Hyperthermic intraperitoneal chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Ovarian Neoplasms, Peritoneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intraperitoneal chemotherapyOther
Perioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in invasive blood pressure in perioperative period
Invasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner
Measured: From start of surgery upto 48 hours after surgery
Changes in body temperature in perioperative period
Body temperature will be measured in degree centigrade by nasopharyngeal temperature probe in perioperative period and changes from baseline will be recorded in a graphical manner
Measured: From start of surgery upto 48 hours after surgery
Changes in cardiac output in perioperative period
Cardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner
Measured: From start of surgery upto 48 hours after surgery
Changes in arterial blood gas in perioperative period
Arterial blood gases will be measured in perioperative period and changes from baseline will be recorded in a graphical manner
Measured: From start of surgery upto 48 hours after surgery
Secondary outcomes (2)
Length of stay in intensive care unit
Length of stay will be measured in days from admission to discharge in intensive care unit
Measured: Upto 30 days after surgery
Mortality
30 days mortality will be noted if death occurred within this period
Measured: Upto 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohan Lal Solanki, Tata Memorial Centre
- Investigators
- Sohan L solanki, Principal investigator, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754115
- Sponsor's protocol ID
- PN 1667
- Status last verified
- Nov 2024
- First submitted
- 29 Mar 2016
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Solanki SL, Agarwal V, Ambulkar RP, Joshi MP, Chawathey S, Rudrappa SP, Bhandare M, Saklani AP. The Hemodynamic Management and Postoperative Outcomes After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Prospective Observational Study. Crit Care Res Pract. 2024 Dec 27;2024:8815211. doi: 10.1155/ccrp/8815211. eCollection 2024.
PubMed 39760061
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Audit of Perioperative Parameters of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)
- ClinicalTrials.gov ID
- NCT02754115
- Acronym / sponsor ID
- PN 1667
- Conditions
- Colorectal Cancer, Ovarian Cancer, Peritoneal Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- 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.
Peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C) and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all microscopic metastasis.
CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC phase, and even in the early postoperative period, with resultant significant morbidity and mortality. Despite that most of the reported patients are in American Society of Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team of anesthesiologist, surgeons and intensivist and other ancillary services can result in good outcome. This study will see the challenges faced by the team regarding the pathophysiological alterations during the CRS with HIPEC in the perioperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- American Society of Anesthesiologist class I, II and III patients
Key inclusion criteria (3 listed)
- Age between 18 to 70 years
- ASA Class I to III
- Colorectal and gynecological oncology cases posted for CRS with HIPC.
Key exclusion criteria (2 listed)
- Age less than 18 and more than 70 years
- ASA Class IV and above
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 |
|---|---|---|
| Hyperthermic intraperitoneal chemotherapyPerioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively | Other | – |
Primary outcome
Changes in invasive blood pressure in perioperative period
Time frame: From start of surgery upto 48 hours after surgery
Invasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner
Changes in body temperature in perioperative period
Time frame: From start of surgery upto 48 hours after surgery
Body temperature will be measured in degree centigrade by nasopharyngeal temperature probe in perioperative period and changes from baseline will be recorded in a graphical manner
Changes in cardiac output in perioperative period
Time frame: From start of surgery upto 48 hours after surgery
Cardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner
Changes in arterial blood gas in perioperative period
Time frame: From start of surgery upto 48 hours after surgery
Arterial blood gases will be measured in perioperative period and changes from baseline will be recorded in a graphical manner
2 secondary outcomes
Length of stay in intensive care unit
Time frame: Upto 30 days after surgery
Mortality
Time frame: Upto 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 39760061Solanki SL, Agarwal V, Ambulkar RP, Joshi MP, Chawathey S, Rudrappa SP, Bhandare M, Saklani AP. The Hemodynamic Management and Postoperative Outcomes After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Prospective Observational Study. Crit Care Res Pract. 2024 Dec 27;2024:8815211. doi: 10.1155/ccrp/8815211. eCollection 2024.
- Individual participant dataSharing planned: Yes
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Sohan L solanki principal investigator
Tata Memorial Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Ovarian Cancer, run by Tata Memorial Centre 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sohan L Solanki, MD (+919869253201, me_sohans@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in invasive blood pressure in perioperative period (time frame: From start of surgery upto 48 hours after surgery). The study lists 4 primary outcomes in all. 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 NCT02754115, which also lists 1 linked publication.
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 21 Nov 2024.