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Pancreas Disease clinical trials

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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: NCT04760847 Not yet recruiting - Pancreatitis Clinical Trials

Intermittent Fasting for Pancreatitis

IFPanc
Start date: May 7, 2024
Phase: N/A
Study type: Interventional

The purpose of this research is to compare intermittent fasting with a standard diet approach for improving the quality of life related to your pancreas disease. Our hope is to improve your symptoms and prevent you from needing to go into the hospital for pancreas-related issues.

NCT ID: NCT04701567 Recruiting - Liver Diseases Clinical Trials

Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI

Start date: June 30, 2020
Phase:
Study type: Observational

This is a retrospective review of images from patient data. There is no recruitment necessary for this study. Research Question: Can advanced multiparametric MRI techniques improve the detection and characterization of focal and diffuse liver disease, accurately assess treatment response and predict patient outcomes based on longitudinal monitoring? Hypotheses: Advanced multiparametric MRI techniques improve the detection, characterization and response assessment of focal and diffuse liver disease and can predict serious liver related outcomes.

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: NCT04556019 Recruiting - Liver Diseases Clinical Trials

Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit

HPB
Start date: January 3, 2019
Phase:
Study type: Observational

The main aims of this study are: 1. - to evaluate post-surgical morbidity and mortality outcomes, following the criteria and the definitions from Claven-Dindo and ISGPS international classifications, of the patients operated by the HPB Surgical Unit. 2. - to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.

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

NCT ID: NCT04438447 Recruiting - Pancreas Disease Clinical Trials

ERAS Versus ERAS Plus Artificial Nutrition in Open Pancreatoduodenectomy

RASTA
Start date: April 14, 2022
Phase: N/A
Study type: Interventional

there is a need of a randomised clinical trial specifically design to explore whether given a full nutritional requirement by parenteral feeding in the first 5 days after surgery coupled with oral food "at will" compared to only oral food "at will", within an established ERAS program, could achieve a reduction of the morbidity burden

NCT ID: NCT04021264 Withdrawn - Liver Diseases Clinical Trials

The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery

Start date: August 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Major abdominal surgery - like non-laparoscopic bowel resection, liver, gastric, or pancreas surgery - is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient with being more awake and crisp more quickly after surgery. It can also reduce cost to the system. A further benefit which has received very little attention so far, is that reducing the amount of inhaled anesthetic given also lowers the environmental footprint created by the anesthetic. The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the epidural block is applied before or after surgery. Patients will have a nerve block catheter (epidural catheter) placed prior to the induction of general anesthetic by an experienced regional anesthesiologist. The epidural catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or dextrose (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a dextrose (sham) or local anesthetic before the patient is woken up.

NCT ID: NCT03772392 Not yet recruiting - Liver Diseases Clinical Trials

Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery

Start date: February 5, 2019
Phase:
Study type: Observational

ERAS protocols have been utilized extensively in abdominal and non abdominal surgery over the past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative care components. Compliance with these protocols is associated with reduced length of stay, reduced morbidity and reduced hospital costs. ERAS protocols within HPB units are les well established with less evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is less established. In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a recent audit identified that that the compliance rate is low with compliance rates as low as 30 per cent in some care domains.