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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06119880
Other study ID # HBP-RCT-004
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2023
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Ruijin Hospital
Contact Weishen WANG, DR
Phone 64370045
Email peanutswey@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT). A prospective randomized controlled study was conducted to comprehensively analyze the perioperative nutritional status of patients undergoing pancreaticoduodenectomy, with the aim of exploring: 1. The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy; 2. The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy; 3. The personalized full process nutrition management strategies based on risk factor stratification.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Gender unlimited, 18-80 years old; - Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases; - Voluntary testing with informed consent. Exclusion Criteria: - Pregnant women and lactating women - Patients with distant metastasis based on tumor staging before surgery; - Tumor recurrence; - Refuse to sign the consent form.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pancreatin Enteric-coated Capsules
pancreatic enzyme replacement therapy
Other:
Routine treatment plan
Routine treatment plan without PERT

Locations

Country Name City State
China Shanghai Ruijin Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abdominal Skeletal Muscle Index (SMI) Measurement of abdominal skeletal muscle area at the third lumbar spine plane using abdominal plain scan CT and comparison of baseline level SMI change rate. 8 weeks post-operation
Secondary Postoperative complications postoperative pancreatic fistula, delayed gastric emptying, postoperative hypoproteinemia; 8 weeks post-operation
Secondary Nutritional indicators Patient generated subjective global assessment (PG-SGA); 8 weeks post-operation
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