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

Yunlu Feng, Doctor

Xiaoyan Wang, Doctor

The screened patients were randomly assigned 25G puncture needles and 22G puncture needles in a 1;1 ratio, based on the computer-generated random order, before receiving an ultrasound endoscope puncture. Each puncture needle puncture lesions 2 needles, the same type of puncture needle tissue samples taken in the same tissue pathology bottle, all tissues after the completion of the necessary cytological smears, are placed in the Formalin solution to send tissue pathology, pathologists do not know the order of distribution of 2 puncture needles to evaluate the tissue results, all pathology results are reported by the hospital pathology center, audit.

25G and 22G Puncture Needles

Multicenter, Randomized, Self-matched Design, Positive Control, Non-inferiority Clinical Study of 25G and 22G Puncture Needles in Solid or Submucosal Pancreatic Masses

A core tissue sample is defined as a sample with an histological structure that is fully used for tissue evaluation of target lesions.

The quality of tissue samples obtained by puncture is assessed by the pathologist, whether intact tissue structure is preserved, and the length of tissue strips

The quality of tissue samples obtained by punctures is evaluated by pathologists, technical success means that puncture 2 needles can obtain sufficient tissue samples for analysis to be evaluated by endoscopy.

Adverse events refer to adverse medical events that occur in the course of research, including punctured complications such as bleeding, abdominal pain, infection, pancreatitis, etc. throughout the study process.

Peking Union Medical College Hospital

Liver Neoplasms

Hematinics

All Drugs and Chemicals

Liver Extracts

to compare open versus minimally invasive pancreatic resection techniques and analyze the different outcome variables from the clinical standpoint

Resection techniques for pancreatic and liver tumors

Colette N Ndjom, MS

Loretta W Bedell, MPH

Alejandro Mejia, MD

Alejandro Mejia, M.D.

The objective of this study is to compare open and minimally invasive pancreatic and liver resection techniques and analyze the different outcome variables from the clinical standpoint.

The plan is to investigate patient survival, length of stay, complication rates, operative time, transfusion rate, 30 and 90-day readmission rate, and hospital charges.

The plan is to conduct a retrospective chart review of patients who have undergone pancreatic and liver resection by using Meditech and Epic. A non-identified database will be created after retrospectively reviewing each patient case involving pancreatic or liver resection at MDMC. The study period will start in January 2006 until December 2020. Variables will include demographics, clinical disease diagnoses, and operative parameters as well as indirect charges from the hospitalizations.

Evaluation of Resection Techniques for Pancreatic Tumors

It will be calculated in days.Minimally invasive techniques are being adopted for complex pancreatic and liver surgery and there is a need to understand if these techniques are advantageous to the patient, if the cost is justified and if the risks are acceptable when compared to the gold standard open surgery.

It will be calculated in days. The days stayed in hospital post-procedure.

Patient may visit physician or hospital for any symptoms or may need hospitalizations.

If any post-procedure transfusion required, will be recorded.

After the procedure any hospital admissions up to 30 days will be recorded.

The hospital charges for the procedure will be recorded.

Methodist Health System

Pancreatitis

Gastrointestinal Agents

Pancrelipase

Pancreatin

Patients who will not receive intraperitoneal drainage following pancreas resection.

Patients who will receive drains, the standard of care treatment, following pancreas resection.

A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

No Drains

A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

Drains

William E Fisher, MD

This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.

The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication. In recent years, advances in interventional radiology have allowed safe percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the routine use of prophylactic drains placed at the time of pancreas resection and rely on percutaneous drainage for the minority of patients who develop a pancreatic fistula.

Hypothesis:

This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade.

Objectives:

Primary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

Secondary:

A. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

B. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

C. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

D. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

E. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

F. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

G. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

H. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

I. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

Pancreas Resection With and Without Drains

A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage

The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics.

This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced

This is the median number of complications per patients.

The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0).

This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported.

This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis.

Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis.

The Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0\~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0\~144. A lower score represents the worst quality of life.

Baylor College of Medicine

Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery

Patients did not receive intraperitoneal drainage following pancreas resection.

No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.

Patients did receive drain(s), the standard of care treatment, following pancreas resection.

Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

A potential weakness of the current study is that it took 5 years to reach targeted accrual.

Amy McElhany, Clinical Research Manager

the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.

60-day ≥ Grade II Complication Rate

60-day ≥ Grade III Complication Rate

Serious Adverse Event (SAE) Rate

All patients

For just the patients with complications

Median Complication Severity Grade

60-day Frequency of Complications

90-day Mortality Rate

Pancreatic_leak_fistula

Postoperative_Abdominal_FluidCollection

Biliary_leak

Enteric_leak

Lymph_Leak

Diarrhea

Gastroparesis_DelayedGastricEmptying

SmallBowelObstruction

Seroma

Intra_abd_abscess

Wound_Dehiscence

Wound_Infection

Fever

Patients who will not receive intraperitoneal drainage following pancreas resection.

No Drains: A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

Patients who will receive drains, the standard of care treatment, following pancreas resection.

Drains: A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

Rate of Specific Complications

Length of Stay for the Index Admission

Crude Cost

Physical well-being subscale

Social/Family well-being subscale

Emotional well-being subscale

Functional well-being subscale

Total FACT-G score

FACT-Pa subscale

Total FACT-Pa score

The result is the quality of score at 30 days.

Composite Quality of Life Scores

Overall Study

for each patient: liver sampling, blood samples ( serum, plasma, PBMC, whole blood), per-endoscopic bile sampling, stool samples, and materials derived from fresh tumors

Tumor samples

Christophe Tournigand, MD-PHD

Ilaria Cascone, PHD

Pr Tournigand

Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies.

Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored.

Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers.

Method: Retrospective and prospective monocentric cohort study

Retrospective and prospective monocentric cohort study

Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

Interactions Between Tumor, Tumor Microenvironment and Immune System in Digestive Cancers : Impact on Survival and Response to Treatment

AP-HP is the owner of the data and no use or transmission to a third party may be made without its prior consent.

Overall survival (OS): vital status (alive/deceased)

Assistance Publique - Hôpitaux de Paris

Antineoplastic Agents

Gemcitabine

bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)

Aroplatin (Liposomal NDDP, L-NDDP)

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase II, the primary objective is to evaluate survival after therapy with Aroplatin and gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Phase I Primary Objective:

* Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.

Phase II Primary Objective:

* Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer.

Phase II Secondary Objective:

* Evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
25G and 22G Puncture Needles	NCT05101772	Submucosal Tumo... Pancreas Tumor		18 Years -	Peking Union Medical College Hospital
Evaluation of Resection Techniques for Pancreatic Tumors	NCT05128890	Surgery Liver Tumor Pancreas Tumor	Resection techn...	18 Years -	Methodist Health System
Evaluation of Resection Techniques for Pancreatic Tumors	NCT05128890	Surgery Liver Tumor Pancreas Tumor	Resection techn...	18 Years -	Methodist Health System
Pancreas Resection With and Without Drains	NCT01441492	Pancreas Tumor Pancreatitis	No Drains Drains	18 Years -	Baylor College of Medicine
Pancreas Resection With and Without Drains	NCT01441492	Pancreas Tumor Pancreatitis	No Drains Drains	18 Years -	Baylor College of Medicine
25G and 22G Puncture Needles	NCT05101772	Submucosal Tumo... Pancreas Tumor		18 Years -	Peking Union Medical College Hospital
Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort	NCT04707365	Colorectal Canc... Pancreas Tumor Biliary Tract T... Immune System a...	Tumor samples	18 Years -	Assistance Publique - Hôpitaux de Paris
Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies	NCT00081549	Pancreatic Neop...	Aroplatin (Lipo...	18 Years -	Aronex Pharmaceuticals
Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies	NCT00081549	Pancreatic Neop...	Aroplatin (Lipo...	18 Years -	Aronex Pharmaceuticals

Spots Global Cancer Trial Database for pancreas tumor