Symptoms and General Pathology

All Conditions

Infections

Nutritional and Metabolic Diseases

Digestive System Diseases

Inflammation

Communicable Diseases

Malnutrition

Sepsis

Ileus

Nutrition Disorders

Pharmaceutical Solutions

All Drugs and Chemicals

Herbal and Botanical

Soybean oil, phospholipid emulsion

Fat Emulsions, Intravenous

Parenteral Nutrition Solutions

Soy Bean

Olive

Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital

Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid. ClinOleic is approved by Health Canada. The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.

Intralipid

ClinOleic

Johane P Allard, MD, FRCPC

Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).

Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.

There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.

The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.

Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions

prealbumin is an hepatic protein that is used in the diagnosis of malnutrition. It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.

Length of stay in the hospital and ICU will be recorded. We will record how many days it took,since admission to the hospital, for the patient to be discharged. This is an expected average of 4 weeks of length of stay.

We will follow the patients from the day of admission until the day of discharge and record the mortality, if applicable. The expected average of hospital stay is 4 weeks.

We will measure weight before, at day 10 and after PN to calculate the BMI at this different points. The last day of PN is whenever the patient is taken off PN. This can vary considerably from patient to patient.

we will record the infections the patients develop during PN until one week after PN

We will measure hand grip strength at baseline (day0) and at day 10 of PN. This is a test that measures the strength of the hand and forearm muscles and is often used as a general test of strength

is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support

we will record antibiotic days from the start of PN until one week after PN is discontinued

hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN

Red blood cell fatty acid composition, particularly the essential fatty acids (linoleic acid and alpha-linolenic acid) will be measured to assess presence/absence of essential fatty acid deficiency

Johane Allard

Professor of Medicine, Director-Division of Gastroenterology

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Biliary Tract Neoplasms

Jaundice

Duodenal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Diseases

Intestinal Neoplasms

Duodenal Diseases

Intestinal Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

hepaticojejunostomy and gastroenterostomy

surgery

endoscopic strategy

Farshad Frozanpor

Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer

Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

Karolinska Institutet

MD, PhD

Hemorrhage

Stomach Neoplasms

Pain

Stomach Diseases

Stomach Cancer

Palliative Radiotherapy to a total dose of 36Gy in 12 fractions

Palliative Radiotherapy

Jeremy Tey, FRANZCR

The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls.

The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%

Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial

Percentage of patients who do not require blood transfusion after radiotherapy

Tan Tock Seng Hospital

National University Hospital, Singapore

Jeremy Tey

Respiratory Tract (Lung and Bronchial) Diseases

Constriction, Pathologic

Airway Obstruction

Respiratory Insufficiency

Respiration Disorders

Respiratory Tract Diseases

give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy

give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation

give the cases whose central airway stricture were caused by neoplasm compression stent placement

give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare

use cryotherapy to delete soft neoplasm tissue in the airway

cryotherapy

use argon plasma coagulation to delete hard neoplasm tissue in the airway

argon plasma coagulation

use stent placement to open the airway compressed by out neoplasm

stent placement

use snare to delete polypoid neoplasm tissue in the airway

deletion tumor tissue by snare

Deguang Mu, Ph.D

Yandong Nan, MD

Faguang Jin, Ph.D

The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture.

The four techniques are：

* cryotherapy
* argon plasma coagulation
* stent
* snare

Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Changhai Hospital

The First Affiliated Hospital of Guangzhou Medical University

Xinqiao Hospital of Chongqing

China Meitan General Hospital

Micro-Tech (Nanjing) Co., Ltd.

Tang-Du Hospital

Cholangiocarcinoma

Klatskin Tumor

Liver Neoplasms

Cholangitis

Bile Duct Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Diseases

Bile Duct Cancer

Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement.

Systemic chemotherapy and bile duct stenting without RFA.

Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction

Intraductal biliary radiofrequency ablation

Johann von Felden, MD

The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are:

* Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)?
* Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).

Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma

• Time-to-first event (during 6 months follow up), i.e. stent dysfunction defined by bilirubin \>5 mg/dl and/or cholangitis (fever \>38.5°C and/or increase in C-reactive protein by at least 3-fold upper limit of normal and at least 20% from baseline without extrahepatic focus and absence of tumor progression) leading to premature stent replacement and/or disruption of chemotherapy (all possible events will be reviewed by a blinded and independent Endpoint Review Committee \[ERC\].)

The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in cancer patients. It is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

The EORTC QLQ-BIL21 consists of 21 questions: 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, in addition to 18 items grouped into 5 proposed scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). The response format is a four-point Likert scale.and designed to more specifically adress side effects.

A high scale score represents a higher response level.

Rate of clinical events defined as per primary outcome after 6 months follow up

Universitätsklinikum Hamburg-Eppendorf

Principal Investigator

Pathological Conditions, Anatomical

A large plastic biliary stent was placed in the bile duct.

Stent placement for bile duct obstruction.

Large plastic biliary stent

Christopher J Gostout, MD

Plastic biliary stents which are a new larger size will remain free of obstructions for a longer period of time than currently used 10 French stents in cancer in the common bile duct.

Malignant obstruction of the extra-hepatic bile duct often leads to jaundice and pruritus and occasionally results in cholangitis and bacteremia. Pancreatic cancer accounts for a large proportion of patients presenting with malignant extra-hepatic biliary obstruction. Most pancreatic cancers are unresectable at presentation, and palliation, including biliary decompression, is often a goal of therapy. Over the last decade, biliary decompression with endoscopically-placed stents during endoscopic retrograde cholangiopancreatography (ERCP) has largely replaced surgical bilioenteric diversion. Biliary decompression via endoscopic stenting alleviates cholestatic symptoms and improves quality of life. When compared to surgery, endoscopically placed plastic stents result in decreased morbidity and a trend towards decreased 30 day mortality. However, surgery is associated with a lower risk of recurrent biliary obstruction.

Stent diameter is an important factor in determining duration of biliary luminal patency. All plastic biliary stents will ultimately occlude due to deposition of bacterial biofilm. The original plastic biliary stents were 7 French (Fr) in diameter, with a patency rate of about 4 weeks. With increases in the size of the working channel of duodenoscopes, the limiting factor in what diameter stent can be deployed, 10 Fr stents were developed, with patency rates of approximately 15 weeks (3-4 months). Until recently, the largest stent that could be deployed with the current endoscopic technology using a conventional duodenoscope of acceptable outer diameter was 11.5 Fr; the limited available data suggest that these stents do not offer more prolonged luminal patency interval compared to 10 Fr stents.

In the early 1990s, self-expandable metal stents (SEMS) became available for use in palliation of malignant biliary obstruction. Once deployed, SEMS achieve larger diameters than plastic stents, which results in a longer median patency interval of approximately six to eight months.\[3, 6, 9-12\] Although effective, metal stents are eight to ten times more costly than plastic stents.

Recently, a large working channel duodenoscope with an acceptable outer diameter has been developed. This prototype duodenoscope allows passage of larger stents, which the investigators have successfully placed in select cases using this prototype. This duodenoscope, manufactured by Olympus Medical Systems Corp., is FDA approved.

The investigators hypothesize that, with the substantially increased luminal diameter, larger plastic stents will provide more prolonged relief of obstructive jaundice in patients with malignant distal common bile duct strictures. If this proves to be true, larger plastic stents may constitute a cost-effective alternative to SEMS, especially in health care systems that cannot afford SEMS.

Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.

Prospective Evaluation of Luminal Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.

Olympus America, Inc.

Mayo Clinic

A large plastic biliary stent was placed in the bile duct for bile duct obstruction.

Pancreatic Cancer Patients

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

The study was terminated early due to difficulty in enrolling subjects and transporting the scope for sterilization.

Christopher J. Gostout

Data were not analyzed, because there were too few subjects to make the outcome measure meaningful. Principal investigator retired before any analysis could be performed.

Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils	NCT01943409	Obstruction Cancer Ileus Malnutrition Surgery	Intralipid ClinOleic	18 Years -	University Health Network, Toronto
Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer	NCT00487851	Pancreatic Neop... Biliary Tract N... Duodenal Neopla...	surgery endoscopic stra...	-	Karolinska Institutet
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial	NCT01341756	Gastric Cancer	Palliative Radi...	21 Years -	National University Hospital, Singapore
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture	NCT02299830	Airway Obstruct...	cryotherapy argon plasma co... stent placement deletion tumor ...	18 Years - 70 Years	Tang-Du Hospital
Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma	NCT06175845	Cholangiocarcin... Klatskin Tumor Bile Duct Cance... Liver Cancer	Intraductal bil...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture	NCT02299830	Airway Obstruct...	cryotherapy argon plasma co... stent placement deletion tumor ...	18 Years - 70 Years	Tang-Du Hospital
Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.	NCT01590394	Stricture Obstruction Cancer	Large plastic b...	18 Years - 85 Years	Mayo Clinic

Spots Global Cancer Trial Database for obstruction

Every month we try and update this database with for obstruction 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 obstruction

Every month we try and update this database with for obstruction 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 obstruction 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.