The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

NCT06119880 | Unknown Phase 4

• 1 other identifier: HBP-RCT-004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy;
2. 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. 3.The personalized full process nutrition management strategies based on risk factor stratification.

Conditions

Pancreatic Exocrine Insufficiency; Pancreatic Enzyme Replacement Therapy; Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative complications

  8 weeks post-operation

• Nutritional indicators

  8 weeks post-operation

Study Arms (2)

PERT Group

EXPERIMENTAL

After surgery, resume diet and begin receiving standard PERT treatment (2 capsules per meal, 1 capsule per snack, taken with meals, starting at a dose of 40000 to 50000 units of lipase) for 8 weeks.

Drug: Pancreatin Enteric-coated Capsules

Placebo Group

PLACEBO COMPARATOR

Follow the routine treatment plan for pancreatic tumors during the perioperative period.

Other: Routine treatment plan

Interventions

Pancreatin Enteric-coated Capsules DRUG

pancreatic enzyme replacement therapy

PERT Group

Routine treatment plan OTHER

Routine treatment plan without PERT

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender unlimited, 18-80 years old;
• Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases;
• Voluntary testing with informed consent.

You may not qualify if:

• Pregnant women and lactating women
• Patients with distant metastasis based on tumor staging before surgery;
• Tumor recurrence;
• Refuse to sign the consent form.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Weishen WANG, DR

CONTACT

64370045; peanutswey@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

CN (1)