Digestive System Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Gastrointestinal Diseases

Gastroesophageal Reflux

Fistula

Gastroparesis

Esophageal Achalasia

Gastric Outlet Obstruction

Pyloric Stenosis

Constriction, Pathologic

Pathological Conditions, Anatomical

Stomach Diseases

Paralysis

Neurologic Manifestations

Idiopathic Achalasia

Cardiospasm

These procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection).

Endoscopic Surgery

Michel Kahaleh, MD

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Our tertiary-care institution performs clinically-indicated various Endoscopic Surgery procedures gastrointestinal indications in more than 800-1000 patients annually.

The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as POEM (Peroral Endoscopic Myotomy), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.

Various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall.

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Data will not be shared with other researchers.

Type, frequency and intensity of adverse events

Chart Review of quality-of-life improvement and overall survival duration

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Neoplasms

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

ERCP guided stent insertion before transection of the gland

stent

Distal pancreatectomy

Urban Arnelo

Farshad Frozanpor

Lars Lundell, Professor

Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.

Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.

B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.

Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.

Karolinska Institutet

Karoliska instuitut

Necrosis

Crohn Disease

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Anti-Inflammatory Agents

Antirheumatic Agents

Antibodies

Immunoglobulins

Certolizumab Pegol

Immunoglobulin Fab Fragments

Tumor Necrosis Factor Inhibitors

Immunosuppressive Agents

Immunologic Factors

Certolizumab pegol

Krassimir Mitchev, MD

To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.

Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas

A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.

UCB Pharma

Endoscopic treatment will consist in placement of a metal stent in a patient with early fistula (\< 15 days) and/or a large fistula orifice, and no abscess, or double pigtail plastic stents if the fistula is older than 15 days and the orifice is small.

Endoscopy

Aymeric Becq, MD

Endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. However, data regarding the yield of this type of treatment is lacking. This study aims to evaluate endoscopic management of this post-operative complication. The main outcome of this prospective observational study conducted in tertiary centers in France is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.

Endoscopy for Post-operative Fistula

Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract

The main outcome is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.

Aymeric Becq

Medical doctor-principal Investigator

Infections

Cholangiocarcinoma

Communicable Diseases

Postoperative Complications

Sepsis

Duodenal Neoplasms

Toxemia

Bile Duct Neoplasms

Biliary Fistula

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Intestinal Neoplasms

Duodenal Diseases

Digestive System Fistula

Bile Duct Cancer

Anti-Infective Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Patients underwent pancreaticoduodenectomy who had intraoperative bile sampling for bacterial examination.

At the beginning of pancreaticoduodenectomy, patients had bile sampling from the gallbladder or from the common bile duct for bacterial examination and study of susceptibility to antibiotics.

Bile sampling for bacterial examination

Jean Pierre Pertek, MD

The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality for patients who underwent pancreaticoduodenectomy.

The hypothesis is that a proportion of post-operative infections after pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the preoperative period.

Pancreaticoduodenectomy is part of the curative treatment of periampullary neoplasms. Postoperative mortality for this procedure is between 1 and 5 %, and morbidity ranging from 30 to 50%. Infectious complications, with pancreatic fistula and gastric delayed empting, are an important part of this morbidity, affecting nearly 35% of patients.

One of the risk factors of infectious complications is the presence of a preoperative obstructive jaundice, due to obstruction of bile ducts by the tumor. In this case, it is proposed to perform a preoperative drainage of the bile ducts, preferably by endoscopic procedure (ERCP), associated with the placement of a endoprosthesis. However, this procedure is controversial, this one increasing postoperative morbidity, and in particular the rate of infectious complications. One explanation of these events is the bacteriological contamination of the bile ducts during the endoscopic procedure. In addition, it has been observed for the patients who have benefited from preoperative drainage, the biliary flora is predominantly polymicrobial and may contain multiresistant nosocomial germs, unlike patients who have not benefited from this procedure, whose biliary flora is predominantly sterile or monomicrobial. This colonization by multiresistant germs may have consequences in the postoperative period, in fact, up to 49% of the germs found in the bile samples are also found in the samples taken during postoperative infectious events. This microbial release could make it more difficult to take care of postoperative infections, with less efficacy of conventional antibiotic treatments.

The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality in patients who underwent pancreaticoduodenectomy. Patients whit colonized bile and patients with sterile bile were compared for these outcomes.

Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.

Central Hospital, Nancy, France

Pancreaticojejunostomy reconstruction used following Whipple surgery.

Pancreaticogastomy reconstruction used following Whipple surgery.

pancreaticojejunostomy vs pancreaticogastrostomy

elijah dixon, MD

Pancreaticoduodenectomy (PD or Whipple procedure) involves the removal of the head of the pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from the common bile duct, Ampulla of Vater, duodenum, neuroendocrine cells of the pancreas, and most commonly the exocrine pancreas). In Canada, cancer of the pancreas is the 11th cancer in terms of new cases/year, and the 5th leading cause of cancer related deaths/year. Following PD the remaining pancreas is re-connected to a portion of the gastrointestinal tract; the pancreas is very soft and difficult to sew and connect safely. The primary cause of complications following PD is related to leak occurring at this connection. Of patients that develop a leak, over half need a second operation, and up to 40% will die. The two main organs that the pancreas may be re-connected to are the jejunum or the stomach. The investigators will compare the rates of pancreatic leakage in two groups of patients randomized to reconnection to either the jejunum or stomach following PD. The goal of this study is to determine which of these methods is safer. The results may change practice patterns across North America and the world. It may in the future prevent many cases of avoidable leakage and the resulting morbidity of this including death. This will therefore reduce the morbidity and mortality of this group of cancer patients.

Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy

Either a radiologically proved anastomotic leak or the continued drainage (via drain, enterocutaneous fistula, or wound) of amylase (or lipase) rich fluid on or after postoperative day 10. This is a clinically relevant definition which has been used in many other reports.

We will use the definition and classification of complications resulting from surgery as put forth by Clavien et al which has been widely adopted in the surgical literature.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study	NCT05041608	Achalasia Gastric Outlet ... Gastroparesis GERD Reflux Fistula Benign Neoplasm	Endoscopic Surg...	-	Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail	NCT00500968	Pancreas Cancer Fistula	stent Distal pancreat...	20 Years -	Karolinska Institutet
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas	NCT00354367	Crohn Disease	Certolizumab pe...	18 Years -	UCB Pharma
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail	NCT00500968	Pancreas Cancer Fistula	stent Distal pancreat...	20 Years -	Karolinska Institutet
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail	NCT00500968	Pancreas Cancer Fistula	stent Distal pancreat...	20 Years -	Karolinska Institutet
Endoscopy for Post-operative Fistula	NCT04446208	Post-operative ...	Endoscopy	18 Years -	French Society of Digestive Endoscopy
Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies	NCT03525067	Pancreatic Canc... Sepsis Bile Duct Cance... Duodenal Cancer Bile Duct; Obli... Post-Op Complic... Post-Op Infecti... Fistula, Biliar... Fistula Delayed Gastric...	Bile sampling f...	18 Years -	Central Hospital, Nancy, France
Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy	NCT00841607	Pancreas Cancer Periampullary C...	pancreaticojeju...	18 Years -	Tom Baker Cancer Centre
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas	NCT00354367	Crohn Disease	Certolizumab pe...	18 Years -	UCB Pharma
Endoscopy for Post-operative Fistula	NCT04446208	Post-operative ...	Endoscopy	18 Years -	French Society of Digestive Endoscopy
Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies	NCT03525067	Pancreatic Canc... Sepsis Bile Duct Cance... Duodenal Cancer Bile Duct; Obli... Post-Op Complic... Post-Op Infecti... Fistula, Biliar... Fistula Delayed Gastric...	Bile sampling f...	18 Years -	Central Hospital, Nancy, France

Spots Global Cancer Trial Database for fistula

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

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