Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Neuroendocrine Tumors

Fistula

Pancreatitis

Pancreatitis, Chronic

Pancreatic Fistula

Pancreatic Pseudocyst

Gastrointestinal Diseases

Pancreatic Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Chronic Disease

Disease Attributes

Digestive System Fistula

Pathological Conditions, Anatomical

Cysts

Pancreatic Cyst

Chronic Graft Versus Host Disease

Pancreatic Cancer

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.

Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.

Stapling closure of the pancreatic stump

Roux-en-Y anastomosis of the pancreatic stump

Manabu Kawai, MD

The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.

The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.

Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.

The primary endpoint in this trial was defined as the incidence of pancreatic fistula .

Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy

Osaka University

Nara Medical University

Kyoto Prefectural University of Medicine

Kansai Rosai Hospital

Hyogo Medical University

Wakayama Medical University

Second Department of Surgery

Only the eligible participant in the study are considered for inclusion in this group.

Pancreatic Cyst Aspiration

Prithvi Patil, MS

Priyanka Priyanka, BAMS, MPH

Bijun Kannadath, MBBS

Nirav C Thosani, MD MHA

The purpose To determine the diagnostic potential of various biological markers in blood and cyst fluid aspirates from patients with Pancreatic Cystic Lesions (PCLs).

Research design This is a 10-year prospective cohort and pancreatic cyst fluid repository study enrolling all patients diagnosed with pancreatic cyst and undergoing the cyst aspiration.

Procedures to be used Blood Sample Cyst Fluid Sample

Data Collection:

Medical Record Number Demographics (age, sex, gender, race) Contact information History of alcohol use and IV and other recreational drugs and narcotics use/abuse Medication history Past hospitalizations, diagnoses, and treatment Physical examination findings Imaging data of abdominal and chest regions, including and not limited to ultrasonography, magnetic resonance imaging (MRI), computed tomography (CT) Future admissions, diagnoses, treatment including histopathological findings of resected specimens and blood reports End of study data: clinical progression of disease, cyst size, wall thickening, calcification, communication with pancreatic duct, string sign, cytology, immunohistochemical findings, assay levels of lipase, amylase CEA (carcinoembryonic antigen), carbohydrate antigen19-9 (CA 19-9), and other biomarkers.

Risks and potential benefits The risks associated with this study are slight discomfort or bruising from the blood sampling and the possible loss of confidentiality if the patient data or information is inadvertently disclosed outside of this study. The patient will not receive any additional benefit from the study aside from those received as part of routine standard of care.

Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may benefit other patients with Pancreatic Cyst Lesions in the future.

A Prospective Study To Identify Predictive Biological Markers In Blood And Cyst Fluid Aspirates From Patients With Pancreatic Cyst Lesions

To identify any correlation between higher expression levels with early progression to malignant changes in the pancreas

The University of Texas Health Science Center, Houston

Assistant Professor

Behaviors and Mental Disorders

Anxiety Disorders

Patients in this group undergo procedure with standard explanation of the procedure itself, so they do not receive and visualize graphic novel.

Patients in this group do receive and visualize graphic novel in addition to standard explanation of the procedure.

Patients in interventional group do receive and visualize graphic novel, which is more informative than standard informed consent.

Graphic novel visualization

Giacomo Emanuele Maria Rizzo, MD

Ilaria Tarantino, MD

Mario Traina, MD

Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety.

This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels.

Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels.

This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment.

Endoscopy with endoscopic ultrasound (EUS) is the main technique, along with laparoscopic surgery, for diagnosing and treating severe and sometimes life-threatening pancreatic disorders. Especially in the case of pancreatic lesions, diagnostic procedures, such as EUS with fine needle biopsy (EUS-FNB), can elicit states of fear and anxiety in patients. Graphic medicine uses sequential (but not always narratively linear) visual storytelling to share health-related experiences or information.To date, there have been no applications in the field of endoscopy, so the aim of the present study is to evaluate - for the first time in the literature - the efficacy of colourful graphic novels in reducing anxiety in adult patients waiting for an endoscopic-guided biopsy for pancreatic lesions.

This is a prospective single center pilot study evaluating the impact of graphic novels on the stress and behaviour of patients with pancreatic lesions undergoing EUS-FNB at an italian tertiary referral pancreatic center. This study is being conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants. The authors will consecutively evaluate all patients with radiological and clinical suspicion of a pancreatic lesion from January 2024 to May 2024. After hospital admission, patients successfully enrolled and accepting participation in the study will be randomly allocated to the test or control group using dedicated software (Random Allocation Software, version 1.0) . A graphic novel will be provided to all patients in the test group, and they will be given the possibility to read it while waiting for the procedure.

The authors created a comic panel consisting of a sequence of 6 colourful vignettes in which the routine procedure of an EUS-FNB is described to the patient. The authors focused on various graphical aspects of comics, such as the facial expressions of the characters and the background, both made to look similar to the effective contexts experienced by patients at the institute. The initial drafts of the six vignettes were created using artificial intelligence and later modified by one author using graphical software.

Assessing Anxiety After EUS-FNB, all the recruited patients will receive the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21). Prior to the endoscopic procedures (i.e., EUS-FNB), these questionnaires will be administered anonymously in a mixed paper-pencil and/or QR Code mode to be used with a personal mobile phone. A physician, nurse or clinical assistant will be present for questions and clarification. The BAI is a 21-question self-report inventory used to assess anxiety severity in adults older than 17 years. Respondents answer questions about common anxiety symptoms, such as numbness, tingling, sweating unrelated to heat, and fear of catastrophic events. The BAI takes approximately 5 to 10 minutes to complete. Scores range from 0 (not at all) to 3 (severe), with higher scores indicating more severe anxiety. Standardized cut-offs classify anxiety levels as minimal, mild, moderate, or severe. The other questionnaire is a modified version of the DASS-21, which originally consisted of 21 items divided into three subscales (anxiety, stress and depression) with seven items each. Focusing on the anxiety and stress subscales, the questionnaire was modified in order to remove the depression subscale. Specifically, the anxiety subscale assesses physiological arousal, situational anxiety and subjective experience of the effects of anxiety, while the stress subscale evaluates chronic non-specific arousal, difficulty in relaxing, nervous tension, irritability, agitation, impatience and overactivity. Each item is rated on a 4-point scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). The total score for each subscale ranges from 0 to 14 in the modified version, with higher scores indicating higher levels of anxiety and stress. This modified version was named mDASS-21 or mASS-14. The mASS-14 has four cut-off points to classify anxiety and stress levels: normal (0-4), mild (5-8), moderate (9-11) or severe (12-14). Since the DASS-21 is a reliable and valid measure of anxiety and stress symptoms with good internal consistency, test-retest reliability and discriminant validity, this study will evaluate its modified version in this scenario. Both the BAI and mDASS-21 used in this pilot study were in the Italian versions to avoid language barriers.

Data Collection Data will be collected prospectively in a dedicated electronic case report form (eCRF) through a secure platform such as RedCap, and will include gender, age, level of education (years or diploma/degree), marital status (married/cohabiting/single), and children/grandchildren. Medical history, including previous clinically relevant conditions, such as hospitalizations, surgeries, chronic medical therapies or familiarity with cancer, will also be collected. Data regarding clinical presentation and lesion characteristics will be collected as well. The scale for intervention evaluation will be an Italian version of the Beck Anxiety Inventory (BAI), DASS-21, Cancer Worry Scale (CWS), STAI-S (State-Trait Anxiety Inventory Form) and the APAIS (Amsterdam Preoperative Anxiety and Information Scale). ECRFs in RedCap will be fully anonymized through the use of an Identification code (ID) and age instead of date of birth. ECRFs will be translated into an electronic spreadsheet for analysis.

Statistical Analysis The analysis will be performed using jamovi software (the jamovi project, version 2.3, 2023) with R language (R Core Team, 2022). Descriptive statistics will be used to analyze the patients' socio-demographic and physical characteristics. BAI and mASS-14 scores will be summarized through mean value, standard deviation (SD), maximum, median and interquartile range (IQR) as necessary. Comparisons between groups will be performed according to the most appropriate statistics (Fisher or χ-squared for categorical variables, parametric or non-parametric statistics for comparisons of continuous variables). Any relation between BAI and mASS-14 scores will be measured through a linear correlation coefficient.

Graphic novel will be visualized by interventional group before EUS-FNB

Graphic Novel for Patients Undergoing EUS-FNB

Graphic Novel on Anxiety and Stress in Patients Undergoing Endoscopic Ultrasound With Fine Needle Biopsy (EUS-FNB) for Pancreatic Lesions

Patients will complete the Beck Anxiety Inventory (BAI) to assess anxiety and stress levels. Each variable will be scored accordingly: 0 (not at all) to 3 (severe), with higher scores indicating more severe anxiety. Standardized cut-offs classify anxiety levels as minimal (0-11), mild (12-23), moderate (24-34), or severe (35-42)

Patients will complete the modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14, to assess anxiety and stress levels. Levels will be classified accordingly: normal (0-4), mild (5-8), moderate (9-11) or severe (12-14)

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy	NCT01384617	Pancreatic Canc... Pancreatic Cyst... Chronic Pancrea... Pancreatic Neur... Pancreatic Pseu...	Stapling closur... Roux-en-Y anast...	20 Years -	Wakayama Medical University
A Prospective Study To Identify Predictive Biological Markers In Blood And Cyst Fluid Aspirates From Patients With Pancreatic Cyst Lesions	NCT02647177	Pancreatic Cyst...	Pancreatic Cyst...	18 Years - 100 Years	The University of Texas Health Science Center, Houston
Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy	NCT01384617	Pancreatic Canc... Pancreatic Cyst... Chronic Pancrea... Pancreatic Neur... Pancreatic Pseu...	Stapling closur... Roux-en-Y anast...	20 Years -	Wakayama Medical University
Graphic Novel for Patients Undergoing EUS-FNB	NCT06268106	Anxiety Pancreatic Canc... Pancreatic Cyst... Stress	Graphic novel v...	18 Years -	The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Spots Global Cancer Trial Database for pancreatic cystic lesions