Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Digestive System Diseases

Neoplasms

Rare Diseases

Inflammation

Metabolic Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Gallbladder Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Gallbladder Cancer

Jill E. Koshiol, M.D.

Background:

The gallbladder is a small organ below the liver. Gallbladder cancer is a leading cause of cancer death among women in Chile. Chile also has among the highest rates of gallbladder cancer and death in the world. Researchers in a high-risk region of Chile want to find out more about this type of cancer. They especially want to know how inflammation affects the way it develops.

Objective:

To better understand the causes of gallbladder diseases and factors that may be associated with them.

Eligibility:

Women ages 50 74 with gallbladder cancer who are covered by the Chilean national health system.

Other people over age 21 with gallbladder disease.

Healthy adults over age 21.

Design:

Participants may be screened with an ultrasound. They may be asked questions about their health.

Participants will have an ultrasound of the abdomen. This can be done at the study clinic or in the hospital or at home. The ultrasound uses sound waves to take pictures of the gallbladder.

Participants will have a physical exam.

Participants will have their mouths looked at for tooth loss, dentures, and gum redness.

Participants will give a blood sample or saliva sample.

Participants will be asked for access to their medical history. They may be asked to allow researchers to keep any samples taken during gallbladder surgery.

Participants will answer questions about their medical history. This will include illnesses, surgeries, medicine use, and family history. It will also include diet and lifestyle habits, such as places where they have lived and worked.

Some participants will have 3 follow-up visits over 6 years.

...

Gallbladder cancer is a leading cause of cancer death among women in Chile, which has among the highest reported gallbladder cancer incidence and mortality rates in the world. Gallbladder cancer provides a particularly good model for understanding the role of inflammation in carcinogenesis since the major risk factor, gallstones, causes substantial inflammation in the gallbladder. Chile also has a high prevalence of obesity, diabetes, and metabolic syndrome, which are increasingly understood as inflammatory disorders, but the extent to which their carcinogenic effects are mediated through inflammatory pathways is unknown.

While the vast majority of gallbladder cancer cases have gallstones, only a small fraction of gallstone patients ever develop gallbladder cancer. Since there is no way to identify this small proportion at risk, gallstone cases are cholecystectomized, which, given large absolute numbers of individuals with gallstones, results in overtreatment of some and under-treatment of others in a high-risk area like Chile. While cholecystectomy is standard treatment for symptomatic relief, there are more people who need surgery than there are surgeons to perform them, and individuals aged 34-49 are prioritized for treatment, regardless of symptoms. This practice may lead to overtreatment among 34-49-year-olds and under treatment of individuals aged 50 and above since they have to wait longer for surgery. At the same time, about 30% of patients with a biliary colic attack will never have another attack, and cholecystectomy does not always lead to the cessation of symptoms. In addition, cholecystectomy has been associated with an increased risk of other digestive diseases. Thus, cholecystectomy may not be needed in all gallstone patients and may in fact increase the risk of cancer in some. Better predictors of risk are clearly needed.

As with other cancers, dysplasia is an important epidemiologic endpoint as the immediate precursor to cancer since the vast majority of gallbladder cancers develop through a histologic continuum of chronic cholecystitis, pseudopyloric metaplasia, incomplete intestinal metaplasia, dysplasia, and cancer. Thus, our aim is to identify risk factors for gallbladder dysplasia and cancer (GDC) and potential non-invasive risk stratification methods, such as ultrasound characteristics alone or in combination with inflammatory markers and patient characteristics, to better understand the etiology and natural history of GDC and to help inform strategies for GDC prevention.

Together with collaborators at Pontifica Universidad Catolica (PUC), we successfully completed a pilot study in Chile that was previously reviewed and approved by SAG and provided baseline data for the proposed study. Our pilot demonstrated high recruitment rates in the target enrollment area (80%) and high rates of questionnaire completion (100%), blood collection (78% population-based controls), and participant retention (93% of eligible completed a follow-up visit). Information from the pilot was used to optimize procedures for the longitudinal study. We also found that both gallstones and gallbladder cancer were associated with systemic immune alterations, which as we previously demonstrated, reflect inflammatory changes in the gallbladder detectable in bile. The next step is to demonstrate that these markers precede GDC by longitudinally measuring their levels among gallstone patients.

We propose to prospectively assess risk factors and early detection markers for GDC by conducting the Chile Biliary Longitudinal Study (BiLS), a cohort study of 6250 individuals with gallstones from the high- risk southern-central region of Chile. Because women are twice as likely to have gallstones and twice as likely to have gallbladder cancer as men, we plan to maximize our screening efficiency and number of outcomes by screening and enrolling women only. This approach is reasonable given that the female gender bias for gallbladder cancer is largely thought to be due to the gender bias for gallstones,1-3 suggesting that in the presence of gallstones, the risk of gallbladder cancer is the same for men and women. In addition, Chile is conducting a general population cohort in a small town in the high-risk area, and we can use the men with gallstones enrolled by the Chilean study to compare to the women in our study. We plan to enroll women with gallstones over 2 years and follow them for 6 years, conducting visits every other year to collect data on the primary exposures of interest, inflammatory markers and ultrasound characteristics, as well as additional exposures of interest, such as infections, genetics, and environmental exposures (e.g., aflatoxin, pesticides).

Chile Biliary Longitudinal Study

Our major exposures of interest are patterns, levels, and changes in inflammatory markers and ultrasound characteristics, with Gallbladder Dysplasia and Cancer as the primary outcome of interest.

National Cancer Institute (NCI)

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Recurrence

Esophageal Neoplasms

Cholangiocarcinoma

Pancreatic Neoplasms

Stomach Neoplasms

Calculi

Cholangitis

Pancreatitis

Pancreatitis, Chronic

Constriction, Pathologic

Jaundice

Duodenal Neoplasms

Pancreatic Diseases

Barrett Esophagus

Esophageal Diseases

Bile Duct Diseases

Choledocholithiasis

Pancreatic Pseudocyst

Jaundice, Obstructive

Pancreas Divisum

Bile Duct Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Pathological Conditions, Anatomical

Chronic Disease

Disease Attributes

Hyperbilirubinemia

Skin Manifestations

Common Bile Duct Diseases

Cysts

Pancreatic Cyst

Duodenal Diseases

Congenital Abnormalities

Digestive System Abnormalities

Esophageal Cancer

Pancreatic Cancer

Bile Duct Cancer

Chronic Graft Versus Host Disease

Stomach Cancer

Acute Graft Versus Host Disease

Any group that went Interventional Endoscopy procedures.

Advanced imaging endoscopic or therapeutic endoscopy

Interventional Endoscopy

Michel Kahaleh, MD

Monica R Gaidhane, MD, MPH

Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ), Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year. Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders. The investigators would like to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients.

Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional Endoscopy in Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

Collection of procedure specific details of all Interventional Endoscopies

Weill Medical College of Cornell University

Chief, Advanced Endoscopy

Polyps

In those who underwent cholecystectomy for benign conditions, the histopathological analysis showed the malignancy.

Cholecystectomy and histopathological evaluation

Cholecystectomy, extended cholecystectomy

Sathaiah Dadi, MS Gen Surg

A retrospective analysis of data, using the Hospital records of all the patients who underwent cholecystectomy for benign conditions at Osmania General Hospital in a year (2019).

A retrospective analysis of hospital records of patients who underwent Cholecystectomy in a year duration (2019) for any benign condition, diagnosed and confirmed histopathologically as Gallbladder Malignancy.

There are a total of one hundred and eighty patients who underwent cholecystectomy at our hospital (Osmania General Hospital) in 2019, out of which seven patients' histopathological diagnosis was gall bladder malignancy. We reviewed all the case's history, cross-checked the histopathological slides, and confirmed the diagnosis. To avoid the bias of covid-19 pandemic in surgical practice we confined the patient records to the pre-pandemic period of one-year duration (2019).

A total of 180 patients underwent cholecystectomy for various benign conditions in one year, out of which seven patients confirmed histopathologically with Gallbladder malignancy.

Total no of patients : 180 Diagnosed with malignancy : 7 percentage 3.8%

Among these seven, three patients converted from laparoscopic to open procedure for difficulty with resection, two patients are posted for surgery considering empyema of gall bladder preoperatively, one patient in view of gall bladder perforation, and for two patients preoperative diagnosis was gall bladder polyp.

Converted from Lap to Open: 3 Pre-op GB Polyp : 2 Perforated GB : 1 Empyema GB : 2

Only one patient is 40 years old and others are more than 50 years, and two of them are males.

Total : 7 100% Males : 2 28.5% Females : 5 71.5%

Out of a total of 180 patients who underwent cholecystectomy, 117 are females and 63 are males

Total : 180 Males : 63 Females : 117

Out of 180, the age distribution is as follows

Age. Percentage 20 - 29 0 30 - 39 0 40 - 49 0.005 \>50. 99.99

It implies that the malignancy rate increases with an increase in the patient's age more than 50years and also with gender (Females \> males).

A Case Series on Incidentally Detected Gallbladder Malignancy

A Case Series On Incidentally Detected Gallbladder Malignancy

Those who underwent cholecystectomy for benign conditions are diagnosed with gallbladder malignancy

Osmania Medical College

MS General Surgery, Principal investigator

Women from the cohort with gallbladder cancer

Women from Chile screened for gallbladder cancer with and without gallstones

Background:

- Chile has the highest diagnosis and death rates of gallbladder cancer in the world. Gallbladder cancer is also the leading cause of cancer death in Chilean women. High rates of gallstones and obesity, as well as genetic concerns, may explain these high rates. Researchers want to study gallbladder cancer in more depth in Chile. A small study must be done to see if a full-scale study is feasible.

Objectives:

- To test the methods and procedures of a small-scale study of gallbladder cancer in Chile.

Eligibility:

* Individuals at least 18 years of age who have gallbladder cancer or gallstones, or are healthy control volunteers.
* Participants will be recruited from four clinical centers in Chile.

Design:

* Participants will be screened with a physical exam and medical history. Because gallbladder cancer has a high fatality rate, family members may be asked to provide additional medical history information if study participants die or become too ill to provide this information.
* Participants will provide blood, urine, stool, hair, fingernail, and saliva samples.
* Gallstones, bile, and tissue samples will be collected from those who have gallbladder removal surgery. Normal and tumor tissue samples will be collected as needed.
* Treatment will not be provided as part of this protocol. This is a data collection study only.

Gallbladder cancer is a leading cause of cancer death among women in Chile, which has among the highest reported gallbladder cancer incidence and mortality rates in the world. Gallbladder cancer provides a particularly good model for understanding the role of inflammation in carcinogenesis since the major risk factor, gallstones, causes substantial inflammation in the gallbladder. Chile also has a high prevalence of obesity, diabetes, and metabolic syndrome, which are increasingly understood as inflammatory disorders, but the extent to which their carcinogenic effects are mediated through inflammatory pathways is unknown.

While the vast majority of gallbladder cancer cases have gallstones, only a small fraction of

gallstone patients ever develop gallbladder cancer. Since there is no way to identify this small

proportion at risk, gallstone cases are cholecystectomized, which, given large absolute numbers of individuals with gallstones, results in overtreatment of some and under-treatment of others in a high-risk area like Chile. While cholecystectomy is standard treatment for symptomatic relief, there are more people who need surgery than there are surgeons to perform them, and individuals aged 34-49 are prioritized for treatment, regardless of symptoms. This practice may lead to overtreatment among 34-49-year-olds and under treatment of individuals aged 50 and above since they have to wait longer for surgery. At the same time, about 30% of patients with a biliary colic attack will never have another attack, and cholecystectomy does not always lead to the cessation of symptoms. In addition, cholecystectomy has been associated with an increased risk of other digestive diseases. Thus, cholecystectomy may not be needed in all gallstone patients and may in fact increase the risk of cancer in some. Better predictors of risk are clearly needed.

As with other cancers, dysplasia is an important epidemiologic endpoint as the immediate precursor to cancer since the vast majority of gallbladder cancers develop through a histologic continuum of chronic cholecystitis, pseudopyloric metaplasia, incomplete intestinal metaplasia, dysplasia, and cancer. Thus, our aim is to identify risk factors for gallbladder dysplasia and cancer (GDC) and potential non-invasive risk stratification methods, such as ultrasound characteristics alone or in combination with inflammatory markers and patient characteristics, to better understand the etiology and natural history of GDC and to help inform strategies for GDC prevention.

Together with collaborators at Pontifica Universidad Catolica (PUC), we successfully completed a pilot study in Chile that was previously reviewed and approved by SAG and provided baseline data for the proposed study. Our pilot demonstrated high recruitment rates in the target enrollment area (80%) and high rates of questionnaire completion (100%), blood collection (78% population-based controls), and participant retention (93% of eligible completed a follow-up visit). Information from the pilot was used to optimize procedures for the longitudinal study. We also found that both gallstones and gallbladder cancer were associated with systemic immune alterations, which as we previously demonstrated, reflect inflammatory changes in the gallbladder detectable in bile. The next step is to demonstrate that these markers precedeGDC by longitudinally measuring their levels among gallstone patients.

We propose to prospectively assess risk factors and early detection markers for GDC by conducting the Chile Biliary Longitudinal Study (BiLS), a cohort study of 6250 individuals with gallstones from the high- risk southern-central region of Chile. Because women are twice as likely to have gallstones and twice as likely to have gallbladder cancer as men, we plan to maximize our screening efficiency and number of outcomes by screening and enrolling women only. Since Chile is conducting a general population cohort in a small town in the high-risk area, will we benefit from the infrastructure that is already in place and be able to compare the women in our study to a set of men with gallstones enrolled by the Chilean study. We plan to enroll women with gallstones over 2 years and follow them for 6 years, conducting visits every other year to collect data on the primary exposures of interest, inflammatory markers and ultrasound characteristics, as well as additional exposures of interest, such as infections, genetics, and environmental exposures (e.g., aflatoxin, pesticides). The cohort will be complemented by an incident case-control study of 300 women with gallbladder cancer and 600 controls with and without gallstones obtained from the cohort participants.

Initial Study of Gallbladder Cancer in Chile

A Pilot Study of Gallbladder Cancer in Chile

Pontificia Universidad Catolica de Chile

Infections

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Wounds and Injuries

Communicable Diseases

Aneurysm

Vascular Diseases

Kidney Calculi

Nephrolithiasis

Leiomyoma

Aortic Aneurysm

Myofibroma

Diverticulitis

Pregnancy, Ectopic

Intraabdominal Infections

Ovarian Cysts

Appendicitis

Cardiac Complexes, Premature

Abdominal Injuries

Aortic Diseases

Gastroenteritis

Cecal Diseases

Neoplasms, Connective and Soft Tissue

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urolithiasis

Urinary Calculi

Male Urogenital Diseases

Diverticulum

Diverticular Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.

Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.

Joshua Broder, MD

Summary

1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis.
2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.

This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications

Wallace H. Coulter Foundation

Duke University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chile Biliary Longitudinal Study	NCT02692911	Gallbladder Can... Nutritional and...		50 Years - 74 Years	National Institutes of Health Clinical Center (CC)
Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders	NCT01438385	Ampullary Cance... Duodenal Cancer Bile Duct Cance... Bile Duct Disor... Gallstones Obstructive Jau... Pancreatic Diso... Colorectal Canc... Esophageal Canc... Barrett's Esoph... Gastric Maligna... Pancreatic Canc... Pediatric Gastr... Cholangiocarcin... Pancreatic Pseu... Acute and Chron... Recurrent Pancr... Cholangitis Bile Leak Biliary Strictu... Pancreatic Divi... Biliary and Pan... Choledocholithi...	Interventional ...	18 Years -	Weill Medical College of Cornell University
A Case Series on Incidentally Detected Gallbladder Malignancy	NCT05606029	Gallbladder Mal...	Cholecystectomy...	18 Years - 70 Years	Osmania Medical College
Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders	NCT01438385	Ampullary Cance... Duodenal Cancer Bile Duct Cance... Bile Duct Disor... Gallstones Obstructive Jau... Pancreatic Diso... Colorectal Canc... Esophageal Canc... Barrett's Esoph... Gastric Maligna... Pancreatic Canc... Pediatric Gastr... Cholangiocarcin... Pancreatic Pseu... Acute and Chron... Recurrent Pancr... Cholangitis Bile Leak Biliary Strictu... Pancreatic Divi... Biliary and Pan... Choledocholithi...	Interventional ...	18 Years -	Weill Medical College of Cornell University
A Case Series on Incidentally Detected Gallbladder Malignancy	NCT05606029	Gallbladder Mal...	Cholecystectomy...	18 Years - 70 Years	Osmania Medical College
Initial Study of Gallbladder Cancer in Chile	NCT01520259	Gallbaldder Can...		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Initial Study of Gallbladder Cancer in Chile	NCT01520259	Gallbaldder Can...		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Point of Care 3D Ultrasound for Various Applications: A Pilot Study	NCT02831556	Appendicitis Evidence of Cho... Gallstones Pregnancy, Ecto... Aortic Aneurysm Kidney Stones Intrauterine Pr... Diverticulitis Abdominal Injur... Tumors Pancreatitis Digestive Syste... Gastrointestina... Intraabdominal ... Intestinal Dise... Pregnancy Vascular Diseas... Uterine Fibroid... Ovarian Cysts Uterine Abnomin... Bladder Abnomin... Testicular Abno... Polyps		-	Duke University

Spots Global Cancer Trial Database for gallstones

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

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