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Pancreas Disease clinical trials

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NCT ID: NCT06466928 Completed - Pancreas Disease Clinical Trials

Total Pancreatectomies in Germany - Epidemiology, Trends,

ToPaGe
Start date: January 1, 2010
Phase:
Study type: Observational

The purpose of this study was to evaluate the real-world mortality rates of total pancreatectomy across Germany and to understand the impact of hospital caseload on surgical outcomes.

NCT ID: NCT06390891 Completed - Pancreas Disease Clinical Trials

Role of Patient Selection for Pancreatic Resections

PatSelPanc
Start date: January 1, 2010
Phase:
Study type: Observational

Pancreatic surgery is complicated and risky, especially for pancreatic cancer. It's been noticed that having these surgeries done at specialized centers can lead to better outcomes and survival rates. However, factors like patient selection and hospital conditions also play an important role. Some studies show that more surgeries done at a hospital might not always mean better results, as the type of patients and procedures can vary. To understand this better, the present study compared outcomes and patient characteristics between high-volume pancreatic centers and others.

NCT ID: NCT06160154 Completed - Pancreas Disease Clinical Trials

Minimally Invasive Robot-assisted and Laparoscopic Distal Pancreatectomy in a Pan-European Registry

Start date: January 1, 2019
Phase:
Study type: Observational

A planned analysis of outcomes among consecutive patients after MIDP from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were intraoperative events, major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

NCT ID: NCT06135233 Completed - Pancreas Disease Clinical Trials

Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:

E-MIPS
Start date: January 1, 2019
Phase:
Study type: Observational

A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

NCT ID: NCT05333991 Completed - Pancreas Disease Clinical Trials

Endothelial Leakage and the Association to Endothelial Biomarkers After Surgery

Start date: August 31, 2022
Phase:
Study type: Observational [Patient Registry]

The primary aim of this study is to investigate fluid loss from the blood stream (''endothelial leakage'') and the damage on the vessel wall (''endothelial function'') during surgery. Cardiovascular complications during surgery are said to have different causes, e.g. lack of fluid in the blood stream (''hypovolemia'') and decreased vascular tone. Hypovolemia can have different causes, one being damage to the endothelial function. During trauma and infection, it has been previously shown, that damage to the endothelial function causes fluid loss from the blood stream. Nevertheless, this has never been demonstrated during surgery. Secondary this study will measure the blood flow using a thermo-camera during surgery. This will together with selected blood tests provide information on various possible causes to hypovolemia. The purpose of this study is to describe and quantify endothelial damage (assessed by selected endothelial biomarkers) and albumin escape rate as a proxy for endothelial leakage (assessed by measuring radioactive 125-I labeled HSA injected postoperatively), combined with assessment of MTS (assessed by Laser Speckle Contrast Imaging (LSCI) and digital thermography). This will allow a detailed description of the surgery's impact on the endothelial integrity and contribute to a better understanding of the physiological changes that occur postoperatively. The study will investigate patients undergoing pancreaticoduodenectomy (Whipple) and total pancreatectomy. These patients have a vast clinical need, being one of the most extensive abdominal surgical procedures with great stress response. The study is a prospective exploratory cohort study and methods include blood sampling pre- and post-operatively, 125-I labeled humane serum albumin postoperatively (and preoperatively if logistically possible) and thermography. The hypothesis of this study is that the extent of endothelial damage measured by selected biomarkers is associated with the level of albumin escape rate after major abdominal surgery. Secondly, inflammation increases albumin escape rate after major abdominal surgery.

NCT ID: NCT05139394 Completed - Emergencies Clinical Trials

Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series

Start date: January 2014
Phase:
Study type: Observational

Pancreaticoduodenectomy is a challenging procedure itself, being even more complex and demanding in emergency settings. Only a few cases of emergency pancreaticoduodenectomy (EPD) are reported in medical literature, usually performed for complex pancreaticoduodenal lesions. EPD has first been mentioned in trauma settings, even fewer cases being reported for non-traumatic indications. The investigators intend to present our experience with this intervention, in a non-trauma surgical centre. Our study is a prospective consecutive case series, that included patients that underwent emergency pancreaticoduodenectomy from January 2014 to May 2021. Data was collected from the electronic system database. The investigators collected data regarding the demographic characteristics of the patients, their medical history, preoperative and postoperative investigations (including blood work and imagistic investigations), surgery related information and postoperative evolution.

NCT ID: NCT04898517 Completed - Pancreas Disease Clinical Trials

Prevention of CR-POPF in PD With the Technique of Connexion the Pancreatic Duct to Jejunum Stented (CONDUCTJE-ST).

CONDUCTJE-ST
Start date: January 1, 2018
Phase:
Study type: Observational

Objective: To assess the efficacy of the "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)" technique to prevent clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy (PD). Summary Background Data: CR-POPF remains the most determining cause of morbidity and mortality after PD. The incidence of CR-POPF (grades B and C, ISGPS) is around 20% and is a potential source of severe secondary complications that are associated with a mortality of up to 40%. Methods: A prospective pilot study included 50 consecutive patients who underwent PD with the CONDUCTJE-ST technique, the steps of which are described, performed by the same surgical team from January 2018 to February 2020. No patient received prophylactic or therapeutic somatostatin or its analogues. The primary endpoint was the incidence of CR-POPF. Secondary endpoints were postoperative mortality and morbidity, hospital course and during the first year of follow-up. In a prospective study we have evaluated a "novel" technique, modification of the preexisting ones, for the reconstruction of the digestive continuity of the corporocaudal remnant in the PD, termed "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)", applicable to any type of pancreatic remnant, regardless of its texture and the diameter of the main pancreatic duct. The study was planned with the objective of achieving a significant reduction in the incidence of CR-POPF, so that CONDUCTJE-ST could be considered as a surgical procedure of choice in the management of the pancreatic remnant in PD.

NCT ID: NCT04609137 Completed - Pancreatic Fistula Clinical Trials

Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)

Early-Dist
Start date: October 13, 2020
Phase: N/A
Study type: Interventional

Main indications for distal pancreatectomy (DP) are pancreatic body and tail tumors including ductal adenocarcinoma, neuroendocrine tumors, and cystic neoplasms. Despite a less invasive operation with lower morbidity compared to pancreatic head surgery, DP is burdened by the occurrence of clinically-relevant postoperative pancreatic fistula (CR-POPF) in a significant proportion of patients. Drain fluid amylase (DFA) on POD 1 (postoperative day 1) > 2,000 U/L appears as the best performing threshold to predict the occurrence of CR-POPF after distal pancreatectomy. Although there is preliminary evidence that early drain removal in the subgroup of patients with DFA1 < 2,000 U/L may reduce POPF, no prospective study has yet evaluated the impact of an early drain removal strategy compared to standard management. The research question of this study is to evaluate to what extent early postoperative drain removal according to a validated DFA1 impact on clinically-relevant POPF rate after distal pancreatectomy in comparison to standard drain management. The primary hypothesis is that, early drain removal will result in a reduced proportion of patients experiencing grade B-C POPF according to ISGPS definition. The proposed study is a two-group, assessor-blind, randomized trial. Participants will be randomly assigned with a 1:1 ratio into one of two groups: (1) standard drain management or (2) early drain removal strategy. In this study adults (>18 years) patients with pancreatic body or tail diseases planned for distal pancreatectomy with or without splenectomy will be enrolled.The primary outcome is the POPF at 90 days after surgery, defined as grade B or C POPF according to ISGPS definition. Participants will be asked to complete some questionnaires in order to assess their general health status, and they will be evaluated at time of hospital admission, at 15 days, at 30 days after surgery (via telephone follow-up), and at 90 days after surgery (via telephone follow-up).

NCT ID: NCT04559490 Completed - Pancreas Disease Clinical Trials

Baby Formula and Health

Start date: September 16, 2020
Phase:
Study type: Observational

The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.

NCT ID: NCT04514198 Completed - Pancreas Disease Clinical Trials

Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy

Start date: March 1, 2020
Phase:
Study type: Observational

AIM To determine association between postoperative pancreatitis and pancreatic fistula OBJECTIVES 1. To determine incidence of Clinically relevant pancreatic fistula (grade B/C) after pancreaticoduodenectomy 2. To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula 3. To determine risk factors for postoperative pancreatitis and postoperative pancreatic fistula Primaryendpoint: Incidence of post operative pancreatitis and post operative pancreatic fistula. Secondaryendpoints: 1. to identify the possible predictors of post operative pancreatitis. 2. to investigate the association between post operative pancreatitis and post operative pancreatic fistula. MATERIAL AND METHODS Study centre: Inpatient admissions in Department of gastroenterology, Asian institute of gastroenterology, Hyderabad Study population: Patients who are supposed to undergo pancreaticoduodenectomy Study design: Prospective observational study Study period: Study will be conducted till desired sample size achieved or March 2020 to march 2022