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Peritoneal Neoplasms clinical trials

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NCT ID: NCT06318793 Completed - Clinical trials for Peritoneal Carcinomatosis

Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis

Start date: September 2012
Phase:
Study type: Observational

A retrospective study of a single-center prospective database of patients who underwent curative CRS-HIPEC for peritoneal carcinomatosis (PC) of colo-rectal cancer (CRC), between September 2012 and July 2023 at Reims Hospital-University was conducted. Inclusion criteria were: patients older than 18 years with a performance status ≤ 2, who underwent complete (no macroscopic residual disease) CRS-HIPEC was performed. Exclusion criteria were the presence of an infectious disease prior to surgery, CRS without HIPEC, incomplete CRS and expressed refusal to participate in the study. During the month prior to surgery, patients underwent a thorough diagnostic workup, including chest and abdominopelvic computed tomography (CT) scans, complete haematological and biochemical tests, and cytobacteriological analysis of urine. Blood tests included leukocytes, neutrophils, lymphocytes, platelet count, albumin and CRP. Within one week before surgery, patients were examined by both the surgeon and the anaesthetist. Variables with a normal distribution are presented as mean-SD, while those with a non-normal distribution are presented as median and range. Categorical variables are presented as counts and percentages. Chi-Square or Fisher's exact test was used to compare qualitative variables. Linear regression analysis was used to assess any association between preoperative inflammatory biomarkers and patient comorbidities and disease characteristics. Preoperative levels of inflammatory biomarkers were compared between patients with no postoperative complication (POC) and patients with POC and major POC using the non-parametric Mann-Whitney U test. Optimal cut-off values for significant inflammatory biomarkers were determined using the Youden index. Receiver operating curves (ROC) were calculated to determine the area under the curve (AUC). Univariable and multivariable analyses including cut-off values of significant biomarkers were performed in a binary logistic regression analysis and expressed as odds ratios (OR). All tests were two-tailed and results were considered significant if the p-value was < 0.05. Statistical analyses were performed using R software (version 4.0.5).

NCT ID: NCT06237582 Completed - Clinical trials for Carcinomatosis, Peritoneal

Inferior Epigastric Lymp Node (IELN) Basin as a Possible Systemic Metastatic Pathway of Ovarian Peritoneal Metastases

OvEpiLyPath
Start date: June 16, 2022
Phase: N/A
Study type: Interventional

The IELN basin could represent a primary LN relay for systemic metastatic dissemination in patients with OPM. This newly described lymphatic pathway of metastatic dissemination of OPM may be involved in certain presentations of peritoneal dissemination. The presence of invaded IELN may represent a new biomarker predictive of the pattern of progression of OPM and a related risk for systemic dissemination.

NCT ID: NCT05547568 Completed - Clinical trials for Peritoneal Carcinomatosis

A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring?

Start date: September 2012
Phase:
Study type: Observational

In this study, the investigators tend to highlight pre and peroperative factors that predict major postoperative complication after a surgery for resection of peritoneal carcinomatosis. Factors associated with major postoperative complications were used to elaborate un predictive nomogram model. A score was assigned for each factor of the nomogram which correspond to the weight of the association of the factor with the occurrence of the major postoperative complication. The nomogram assessed the probability of major postoperative complication after surgery by adding up the scores identified on the "Points" scale for each factor. The total score projected from the "Total points" axis to the "Risk of major postoperative complication" axis, indicated the probability of major postoperative complication occurrence. A cut-off of total score was calculated to identify patients at low or high risk for major postoperative complications. The developed nomogram may be a helpful tool to adapt postoperative monitoring of patients after surgery of peritoneal carcinomatosis resection according to the risk of occurrence of a major postoperative complication.

NCT ID: NCT05300789 Completed - Colon Cancer Clinical Trials

Metachonous Peritoneal Carcinomatosis Incidence After Curative Surgery for pT4 Colon Cancer Patients

Start date: March 1, 2021
Phase:
Study type: Observational

This is an observational retrospective cohort study to determine metachronous peritoneal carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic exam corresponding to pT4 tumors. Based on a sample size calculation of 1152 patients, a retrospective review of a three year period of every participant hospitals, 50 in total, of different characteristics, was stablished. Demographic, clinical, operative, histologic and oncologic follow-up variables were recorded.

NCT ID: NCT05083338 Completed - Clinical trials for Malignant Solid Neoplasm

Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy

Start date: August 10, 2021
Phase:
Study type: Observational

This study learns if depression, anxiety, and catastrophizing (thought patterns that prompt people to expect the worst) are associated with chronic pain after surgery among patients who are scheduled to have cytoreductive surgery with intraoperative hyperthermic chemotherapy. Information from this study may improve the understanding of persistent and chronic postsurgical pain integrating multiple layers of biological and behavioral sciences.

NCT ID: NCT04950166 Completed - Clinical trials for Peritoneal Carcinomatosis

A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Peritoneal Metastases in Patients Undergoing Cytoreductive Surgery

Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

Peritoneal carcinomatosis (PC) results from the metastasis of a primary cancer of the peritoneum (e.g., appendiceal, ovarian, uterine, colorectal, and gastric cancers) that then disseminates throughout the abdominal cavity. Historically progression to PC was considered terminal and resulted in survival times on the scale of a few months with palliative care being the best option for patients. More recently, cytoreductive surgery (CS) has emerged as a means to prolong and improve patient lives with a median increase in survival of up to ~5 years. It has been reported that for every 10% increase in cytoreduction there is a 5.5% increase in median survival time. In addition to surgical tumor debulking within the peritoneal space, it has also been shown that coupling surgical intervention with hyperthermic intraperitoneal chemotherapy (HIPEC) can have an even greater impact on patient outcomes. Pegsitacianine, a micellar fluorescence agent, exploits the ubiquitous pH differences observed between cancerous and normal tissues. This in turn, provides a highly sensitive and specific fluorescence response after localizing within the tumor microenvironment, thus allowing the detection of primary tumors, their margins, metastatic disease, and tumor-containing lymph nodes.

NCT ID: NCT04904042 Completed - Clinical trials for Peritoneal Carcinomatosis

Study of Safety and Efficiency of the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface.

Plasmajet
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Neutral argon plasma vaporization shows little damage to normal tissue and allows a complete removal of tumor tissue, that is, without leaving any cell debris viable tumor. Our primary objective is to evaluate the effectiveness and safety of neutral argon plasma on peritoneal implants with different dosimetry in vivo and ex vivo.

NCT ID: NCT04898842 Completed - Colorectal Cancer Clinical Trials

Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet

BOUNCED
Start date: March 2, 2021
Phase: N/A
Study type: Interventional

Bowel obstruction is a common complication in patients with ovarian, peritoneal and bowel cancer due to a mass or spread of disease, causing narrowing to the gut, as these cancers can grow on the bowel surface. Certain foods may lead to symptoms such as pain, bloating, feeling full, feeling sick, vomiting and difficulty passing a bowel motion. There is limited evidence to establish the best diet to follow when someone is diagnosed with the risk of bowel obstruction and is experiencing symptoms after eating and drinking. The Dietitians at the Royal Surrey have developed a 4 stage bowel obstruction diet which they have been using with patients for 3 years. The 4 stages are clear fluids, all thin liquids, low fibre soft smooth diet, low fibre soft sloppy diet. Depending on the severity of symptoms and the risk of a blockage, patients are asked to follow a certain stage of the diet. They are advised to move up and down the stages as symptoms improve or get worse. This feasibility study aims to investigate if the diet can be used and is effective in clinical practice. The objectives are to see if this diet is easy to follow, can reduce symptoms of bowel obstruction, can improve quality of life, and reduce admissions to hospital because of bowel blockages. Patients at risk of bowel obstruction from colorectal or ovarian cancer are eligible to participate. They will remain in the study for a period of 4 weeks, during which time they will be asked to complete a diet diary and 3 questionnaires.

NCT ID: NCT04879953 Completed - Clinical trials for Carcinomatosis, Peritoneal

Effect of the PIPAC on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

Start date: February 1, 2020
Phase:
Study type: Observational

Pressurised intraperitoneal aerosol chemotherapy is a new surgical technique, developed for the treatment of initially unresectable peritoneal carcinomatosis. The objective of this study was to compare the results of PIPAC associated with systemic chemotherapy with those of systemic chemotherapy alone in patients with gastric peritoneal carcinomatosis without metastasis other than peritoneal, and WHO performance status <3.

NCT ID: NCT04744688 Completed - Clinical trials for Postoperative Complications

Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment

CONTEST
Start date: April 6, 2021
Phase:
Study type: Observational

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical treatment. However, perioperative changes in coagulation and fibrinolysis are only sparsely reported in the literature.The mainstay of treatment with curative intend of none-advanced colorectal cancer is minimally invasive laparoscopic surgery followed by adjuvant chemotherapy. The approach is considered associated with a lower risk of thromboembolic disease than open surgery. Despite differences in extent of surgery and thromboembolic risk the same extended thromboprophylaxis regimen for 28 days is currently prescribed to patients undergoing cytoreductive surgery with HIPEC as well as minimally invasive rectal cancer resection. This study aims to investigate all parts of the coagulation system and fibrinolysis, and thereby thromboembolic risk and potential bleeding in two groups of patients with different extent of surgical trauma: 1) Colorectal cancer patients undergoing cytoreductive surgery with HIPEC and 2) rectal cancer patients undergoing minimal invasive rectal cancer resection. Our hypothesis is that patients undergoing cytoreductive surgery with HIPEC are exposed to more aggravated alterations of coagulation and fibrinolysis than patients undergoing minimally invasive rectal cancer resection.