Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Adenocarcinoma

Intestinal Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Intestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Neoplasms, Cystic, Mucinous, and Serous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma, Mucinous

Rectal Neoplasms

Colonic Diseases

Patients with mrEMVI positive rectal cancer

Patients with mrEMVI negative rectal cancer

Gina Brown

Extramural venous invasion (EMVI) is the spread of microscopic tumour cells into the veins around the tumour. Rectal cancer treatment has improved greatly over recent years. However, it is important for us to learn as much about the tumours as possible in order to develop newer therapies. Current treatments may benefit from new genetic information relating to the cancer. We hope to identify genetic differences in certain types of rectal cancer which will allow future treatments.

Neoadjuvant chemoradiotherapy (CRT) is widely accepted as beneficial to selected patients in terms of decreased risk of local recurrence and overall survival. Current management of rectal cancer involves risk stratification through pre-operative staging leading to formulation of treatment strategy. Very little is known about the long-term outcomes and response to CRT on MRI detected extramural venous invasion (mrEMVI). Although mrEMVI is accepted as a marker of poor prognosis, whether it has a predictive value and should be specifically treated is not known.

Molecular and genetic profiling provides us with an opportunity to understand the underlying mechanisms which govern clinical behaviour in rectal cancer. Using high-throughput technology such as tissue microarray analysis allows large-scale analysis of specimens in a relatively short amount of time. It offers the ability to compare the molecular profiles of different subtypes of rectal cancer such as mrEMVI-positive and -negative tumours and whether any changes are observed following CRT. This can then be correlated with clinical behaviour over the medium and long-term with regards to local recurrence, distant metastases and overall survival.

This study will identify important differences between key rectal cancer tumour subtypes. Identification of reliable pathological markers of EMVI pathways (from both the primary tumour sample, but more importantly from the pre-operative biopsies) has real potential for taking us a step closer to more personalised management of rectal cancer by establishing prognostic biomarkers reflective of disease type, but also through the underlying biology that may be highlighted (with its promise of therapeutic translation).

Histopathology samples taken after rectal tumour removal surgery will be analysed using micrarray techniques. The pathological tissue microarrays (TMAs) will be generated using the Alphelys Tissue Arrayer Minicore®3 system. Markers that will be evaluated will be initially directed at epithelial to mesenchymal (EMT) transition pathways, as our preliminary studies suggest that this phylogenetically conserved molecular program has important roles in tumour dissemination and resistance to conventional chemotherapy.

Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer (MARVEL) Trial

Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer

mrEMVI Regression Grade Scoring Table: Grade 5 - No response (intermediate signal intensity, same appearances as original tumour) Grade 4 - Slight response (little areas of fibrosis or mucin but mostly tumour) Grade 3 - Moderate response (\>50% fibrosis or mucin, and visible intermediate signal) Grade 2 - Good response (dense fibrosis; no obvious residual tumour, signifying minimal residual disease or no tumour) Grade 1 - Radiological complete response (rCR) (linear/crescentic 1-2mm scar in mucosa or submucosa only.)

Pelican Cancer Foundation

Royal Marsden NHS Foundation Trust

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Arrhythmia Agents

Channel Blockers

Pharmaceutical Solutions

Anti-Infective Agents

Anesthetics

Lidocaine

Anesthetics, Local

Ethanol

Sodium Channel Blockers

Diuretics, Potassium Sparing

Anti-Infective Agents, Local

EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.

EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.

The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.

Mark Topazian, MD

Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy.

The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in \<10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.

EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.

After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Data sharing can be arranged and will require IRB approval

Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability

Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)

Mayo Clinic

Professor of Medicine

Pancreatic Cyst Ethanol Injection

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Only subjects who received the study intervention, endoscopic ultra sound (EUS)- guided ethanol lavage were included in the baseline analysis.

Sample size was small, and a control group was not included. Neither cyst histology not degree of epithelial ablation was assessed by surgical resection in any of the study participants.

Dr. Mark Topazian

Number of participants with adverse events

Number of participants without adverse events

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Complete ablation of treated cyst

Greater than or equal to 80% cyst volume reduction

Less than 80% cyst volume reduction

Cyst volume increase

Number of Subjects With Complete or Partial Ablation of the Treated Cyst

Endoscopic ultrasound (EUS)-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.

Overall Study

Behaviors and Mental Disorders

Quality of Life

Low Rectal Cancer defined on MRI as a cancer within 6cm of the anal verge

Brendan Moran

The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary, multi-centre study. However, there were differences in patient outcome, dependent upon the position of the tumour in the rectum and its height above the anal verge. Whilst the outcome was excellent for patients who underwent an anterior resection, the outcome, based upon margin involvement and quality of the specimen, was poor for patients who underwent an abdomino-perineal excision for low rectal cancer.

It is proposed that accurate MRI staging pre-operatively will allow the correct patients to receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the resection margins appear threatened so that the operation can be modified to take this into account. The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate of CRM positivity rate in low rectal cancer and to assess the difference in global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.

The aim of this study is to reduce the positive margin rate of 30% to around 15%. The study is an international multicentre, prospective, observational study, whereby patients with biopsy-proven low-rectal cancer (lower edge of the tumour \< 6cms from the anal verge on MRI), will be recruited from participating centres, having given informed, written consent. Data from the radiology, surgical and pathological aspects will be collected and analysed centrally at the Royal Marsden Hospital. The patient's medical records will be reviewed for five years post surgery, and the patients will also be followed up by quality of life questionnaires. This project aims to show that in low rectal cancer, improved local control and survival can be achieved through a reduction in the involved CRM rates by MRI-planned surgery and selective pre-operative therapy. It also aims to assess the ability to predict disease recurrence and to provide an assessment of disease-free survival and overall survival.

Low Rectal Cancer Study (MERCURY II)

The Low Rectal Cancer Study.

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Procedure/Surgery Thermal Radiofrequency Ablation under endoscopic ultrasonography guidance of the pancreatic neuro endocrine tumor or mucinous cyst.

Pancreatic radiofrequency ablation under endoscopic ultrasonography guidance Procedure under general anesthesia Punction of the pancreatic lesion and aspiration of the liquid if present / then thermal ablation with a 18G needle (50 W during 10 secondes) - only one session

Radiofrequency Ablation under EUS

Marc Barthet, MD, PhD

Advances in conventional imaging (abdominal ultrasound, CT scan, MRI) are so great that chance to discover a incidental solid or cystic pancreatic lesion is becoming usual. Endocrine tumors have variable malignant potential depending on their size, some malignancy for lesions larger than 2 cm and indefinite for a smaller size. The branch-duct like IPMN (intraductal papillary mucinous pancreatic tumor) involving the pancreatic secondary ducts represent half of pancreatic cystic tumors and may degenerate into 5 to 10% of cases. Signs and risk of degeneration are the presence of mural nodules greater than 5 mm and size \> 3 cm, although the latter criterion is discussed. Mucinous cystadenomas could degenerate between 30 and 50% of cases even though the role of size is much discussed (\<4 cm). The follow-up imaging is performed using MRI and endoscopic ultrasonography (EUS). A fine needle aspiration for cytology and histology is possible and determination of biological markers is useful. But cytology is often unprofitable due to the poor cellular profile of the cystic pancreatic tumor. Once the diagnosis of suspected malignancy, the patient should be referred to the surgeon for pancreatic resection more or less extensive. But this attitude is facing a significant operative risk with up to 30% of morbidity and mortality between 1 and 3 % for cephalic resections. Some patients with high post operative risks are inoperable. For these reasons, some teams have proposed the destruction of the walls of the cyst under EUS, US or CT control by washing with absolute alcohol content of cystic tumor.

An interesting alternative endoscopic destruction would be the use of radio frequency ablation technique (RFA). RFA is a recognized technique for local tumor destruction by delivering thermal energy to obtain coagulation necrosis of the lesion. Taewong Medical ™ recently developed a radiofrequency needle EUSRA® coupled with a combo VIVA ™ generator for applying RFA sub EUS control. But no prospective study is available at this date regarding the treatment of the cystic or solid tumoral pancreatic lesion with this technique. The primary endpoint of the present study is to investigate the feasibility and safety of this guided radiofrequency probe EUS for the treatment of pancreatic endocrine tumors or inoperable pancreatic cystic tumors. The secondary objective will be the efficiency.

Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor

Efficacy and Safety of Radiofrequency Ablation Under Endoscopic Ultrasonography Guidance in Pancreatic Neuroendocrine and Cystic Tumor

Decrease of the size of the lesion using CT-scan and tumoral response using the Response Evaluation Criteria in Solid Tumors criterion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular, Pathologic and MRI Investigation of the Prognostic and Redictive Importance of Extramural Venous Invasion in Rectal Cancer (MARVEL) Trial	NCT01995942	Adenocarcinoma Rectal Diseases Colorectal Neop... Adenocarcinoma,... Carcinoma Neoplasms, Glan... Neoplasms by Hi... Neoplasms Neoplasms, Cyst... Intestinal Neop... Gastrointestina... Digestive Syste... Neoplasms by Si... Digestive Syste... Gastrointestina... Intestinal Dise...		18 Years -	Royal Marsden NHS Foundation Trust
Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms	NCT02158039	Neoplasms, Cyst...	Ethanol Lidocaine	18 Years -	Mayo Clinic
Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms	NCT02158039	Neoplasms, Cyst...	Ethanol Lidocaine	18 Years -	Mayo Clinic
Low Rectal Cancer Study (MERCURY II)	NCT02005965	Adenocarcinoma Adenocarcinoma,... Carcinoma Neoplasms, Glan... Neoplasms by Hi... Neoplasms Neoplasms, Cyst... Colorectal Neop... Intestinal Neop... Gastrointestina... Digestive Syste... Neoplasms by Si... Digestive Syste... Gastrointestina... Intestinal Dise... Rectal Diseases		18 Years -	Royal Marsden NHS Foundation Trust
Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor	NCT02330497	Pancreatic Tumo... Endocrine Tumor Neoplasms, Cyst...	Radiofrequency ...	18 Years - 85 Years	Société Française d'Endoscopie Digestive
Low Rectal Cancer Study (MERCURY II)	NCT02005965	Adenocarcinoma Adenocarcinoma,... Carcinoma Neoplasms, Glan... Neoplasms by Hi... Neoplasms Neoplasms, Cyst... Colorectal Neop... Intestinal Neop... Gastrointestina... Digestive Syste... Neoplasms by Si... Digestive Syste... Gastrointestina... Intestinal Dise... Rectal Diseases		18 Years -	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for neoplasms, cystic, mucinous, and serous