Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patient randomizes to metal or plastic insertion prior to Whipple procedure

Plastic and metalic stent inserion

Lars Enochsson, MD, PhD

Urban Arnelo, M.D.

Lars Lundell, Professor

Randomized study comparing the effect of plastic stents to that of expandable metal stents as pre-operative drainage of the bile ducts prior to Whipple operation.

Patients suffering from a locally invasive tumour process in the Periampullary area usually seek medical attention because of jaundice. Not only do patients suffering from jaundice show significant symptoms of exhaustion and purities, but they are also at higher risk for developing post-operative complications. Experimentally, the liver exhibits a reduced capacity for tolerating ischemia in the presence of jaundice. Several different etiologic factors suggest cause complication such as presence of toxic substances as bilirubin and bile salts, impaired nutritional status, effects of endotoxins, bacterial translocation, modulation of the inflammatory cascade with cytokine release, reduction of cellular immunity and nutritional. These complications primarily consist of septic complications (cholangitis, abscesses, and leakage), haemorrhage, impaired wound healing and renal disorders. Summarily, these issues have motivated pre-operative bile flow drainage by way of stent. Traditionally, pre-operative bile flow drainage has been achieved by insertion of a EP because these are considered easy to remove and cause less tissue reaction in the bile ducts. However, multiple studies have found the disadvantage with the EP is that it provides poorer bile drainage than the SEMS.

In palliative situations, metal stents have been associated with fewer side-effects in the form of fever relapse of jaundice, etc. These effects are likely due to better bile flow through the stent. It remains unclear if metal stents can provide similar advantages in the curative situation.

Preoperative Stent Study

Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy

Karolinska Institutet

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure")

staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS)

primary tumor resection

Alessio Giordano

Sfogli Anna

CROSCO-1 study is a national, multi-center, prospective observational study presenting patients to the emergency departments of the participating centers with obstructive left colon cancer (in the absence of metastases and peritoneal carcinomatosis) undergoing primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure") or staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS).

The main questions it aims to answer are:

* the Stoma rate at 1 year after tumor resection
* the 30-day and 90-day major morbidity and mortality
* 1-year quality of life (EQ-5D-5L test)
* Timing of chemotherapy initiation and type of chemotherapy regimen. Participants will have an obstructive left colon cancer localized (no peritoneal carcinosis or distant metastasis).

Researchers will compare: primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or an "Hartmann's procedure" with a staged resection after endoscopic stenting with SEMS.

Since surgical and oncological outcomes of the different treatment strategies for obstructing left colon cancers have not been studied on a large scale globally, we launched the CROSCO-1 study intending to compare the clinical results of all these therapeutic regimens in a cohort of patients treated for obstructive left-sided colorectal cancer (CRC).

The primary aim of the CROSCO-1 (Colonic Resection, stOma or self-expanding metal Stents for obstruCtive left cOlon cancer) study is to describe the outcomes of the management of emergency presentations of obstructive left CRC with colorectal resection with or without primary anastomosis versus the staged approach with SEMS insertion and subsequent colorectal resection. The primary aim of the CROSCO-1 study will be the 1-year stoma rate of patients undergoing primary emergency surgical resection (Hartmann procedure or primary resection and anastomosis) compared with patients undergoing staged resection (emergency endoscopic treatment with SEMS followed by elective resection). Other outcomes will be 30-day and 90-day major morbidity and mortality, 1-year quality of life, and the timing and type of chemotherapy initiation in the two groups.

Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer

Colonic Resection, stOma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer. The CROSCO-1 Multicenter, Prospective Cohort Study

all individual participant data (IPD) that underlie results in a publication

the number of stomas after 1 year of primary surgery with tumor resection

mortality (Overall survival) after 30 and 90-days

The EQ-5D-5L is an instrument to describe the quality of life with a state system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. In this first part, the patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions with graduate answers from 1 (no problem) to 5 (extreme limitations). The aggregation of the responses forms a five-digit number representing the patient's health status. in the second part, the patient is asked to indicate an assessment using a visual analog (VAS) graphically represented by a graduated scale ranging from 0 (the worst possible state of health) to 100 (the best possible state of health) on which the interviewee indicates his or her perceived level of health.

data for chemotherapy initiation in both groups of study

type of drugs regimen in both groups of study

Azienda Sanitaria di Firenze

Principal Investigator

Behaviors and Mental Disorders

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Quality of Life

After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse

Standard contact via Hotline and traditional referring methods

home visits by specialist nurse 2 times and 1 phonecall

Home visits

standard

Ole Steen Bjerring, MD

Michael B Mortensen, MD, PhD

Bjerring, MD

Mortensen, MD, PhD

Michael B Mortensen, MD,PhD

The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.

The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or gastro-esophageal junction (cardia), who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.

Quality of Life With Esophageal Stent Trial

Prospective, Randomized Trial of the Effects on HRQoL, Cost-Utility and Reintervention Rate, of Nurse Home Visits, in Patients With SEMS Treated Malignant Disease in the Esophagus and Cardia.

Odense University Hospital

Michael Bau Mortensen

MD, PhD

Symptoms and General Pathology

Biliary Tract Neoplasms

Constriction, Pathologic

Biliary Tract Diseases

Endoscopic stenting

Truls Hauge, MD,PhD

Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal stents(SEMS)is an alternative to palliative surgery and other palliative treatment options.The method has expanded to include patients with malignancies in the esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies have reported treatment with SEMS to be safe and effective. Prospective studies,and especially studies regarding Quality of Life improvement are needed.

PURPOSE:

The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stents(SEMS)in a defined population i Norway, especially Quality of Life changes.

The study is divided into four projects:

1. Establish a central register over all patients with malignant GI-obstruction who are treated with SEMS in the Eastern health region in Norway .Treatment incidence, methods used, treatment effect,complications related to the procedure,Need for reinterventions, hospitalisations and survival will be studied.
2. Quality of life(QoL) studies will be performed before and 14 days after treatment.The EORTC QLQ C30 and EORTCs organospecific modules will be used.
3. Gastric emptying before/after stent will be studied.
4. Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Stent Study	NCT00501176	Pancreas Cancer	Plastic and met...	20 Years -	Karolinska Institutet
Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer	NCT05801211	Colon Cancer	primary tumor r...	18 Years -	Azienda Sanitaria di Firenze
Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer	NCT05801211	Colon Cancer	primary tumor r...	18 Years -	Azienda Sanitaria di Firenze
Quality of Life With Esophageal Stent Trial	NCT01044511	Esophageal Canc... Gastro-esophage...	Home visits standard	18 Years -	Odense University Hospital
Endoscopic Stenting of Gastrointestinal Cancer	NCT00422409	Gastrointestina... Biliary Tract N...	Endoscopic sten...	18 Years -	Oslo University Hospital

Spots Global Cancer Trial Database for sems

Every month we try and update this database with for sems cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sems

Every month we try and update this database with for sems cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sems cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.