Skip to content

A multicenter, prospective, randomized controlled clinical study of ultra-early open transoral diet in mild hypertriglyceridemic acute pancreatitis

A multicenter, prospective, randomized controlled clinical study of ultra-early open transoral diet in mild hypertriglyceridemic acute pancreatitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078145
Enrollment
Unknown
Registered
2023-11-29
Start date
2023-06-27
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemic acute pancreatitis

Interventions

Immediate Feeding Group:Start low-fat solid diet within 12 hours of onset
Conventional Feeding Group:No trial intervention, routine medical disposition process

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18-55 years old; (2) Meet the diagnostic criteria for AP, as well as the diagnostic criteria for HTGAP, and the severity is judged to be mild. ?AP diagnostic criteria: a, Acute, persistent abdominal pain; b. Serum amylase activity is elevated to more than three times the upper limit of normal value. c. Imaging suggests morphological changes in the pancreas. AP can be diagnosed in patients who meet at least two of the three AP diagnostic criteria. ? HTGAP diagnostic criteria: triglyceride (TG) = 11.30 mmol / L, serum celiac disease; or after fasting and other factors, the patient's serum TG between 5.65 mmol / L - 11.30 mmol / L. ? Mild AP: meets the diagnostic criteria for AP without organ failure and local or systemic complications. (3) Not currently participating in other research programs; (4) Agreed to participate in this research project and signed the informed consent; (5) Better compliance. (6) Onset time less than 12 hours.

Exclusion criteria

Exclusion criteria: (1) Patients with localized complications (pancreatic necrosis, pseudocyst, pancreatic abscess, etc.) or organ failure (respiratory, cardiovascular, or renal failure, which may involve one or more organs) after admission that meet the criteria for moderately severe pancreatitis; (2) Patients with the following risk factors on the initial risk assessment predictive of a severe disease course, according to the 2013 American College of Gastroenterology (ACG) guidelines: Patients with one of the following patient characteristics: ? >55 years of age; ? Obesity (BMI >30 kg/m2); ?Altered mental status; Presence of Systemic Inflammatory Response Syndrome (SIRS) Presence: fulfillment of >2 of the following criteria. ? Pulse rate >90 beats/min; ? Respiratory rate >20 times/minute or PaCO2 >32mmHg; ?Body temperature >38? or 12,000 or 10%; Have one of the following altered laboratory test results: ? BUN >20 mg/dl or progressive elevation of BUN; ? HCT >44% or progressive elevation of HCT; ?Progressive increase in creatinine; ?CRP >150mg/L; With one of the following changes in imaging findings: pleural effusion, pulmonary infiltrates, multiple or extensive extrapancreatic effusions. (3) Pancreatitis of other etiologies: e.g. biliary pancreatitis, alcoholic pancreatitis; (4) Suffering from gastrointestinal diseases such as colon cancer, inflammatory bowel disease, irritable bowel syndrome, necrotizing small bowel colitis, and celiac disease; (5) Suffering from serious organic diseases such as cancer, coronary heart disease, myocardial infarction, and stroke; (6) Physical disability, or other causes of life can not take care of themselves, can not clearly recall, answer questions.

Design outcomes

Primary

MeasureTime frame
Length-of-stay;

Secondary

MeasureTime frame
Hospitalization cost;Incidence of dietary intolerance;Incidence of complications;VAS score;Inflammation indicators;

Countries

China

Contacts

Public ContactZeng yue

Shanghai General Hospital

carrie_1004@163.com+86 186 2162 5166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026