Early Oral Feeding for Patients After Pancreaticoduodenectomy

Pancreatoduodenectomy Clinical Trial

Official title:

Clinical Efficacy Analysis on Early Oral Feeding Versus Nasojejunal Early Enteral Nutrition for Patients After Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573399
• Other study ID #: ChanghaiH-PP11
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study intends to retrospectively analyze the patients who underwent pancreatoduodenectomy and compare the safety and feasibility between early enteral nutrition through nasojejunal tube and early oral feeding after pancreatoduodenectomy. This study is expected to revise the guidelines for early nutritional support after pancreaticoduodenectomy, reduce postoperative complications, and provide better guidance for clinical work.

Description:

Pancreaticoduodenectomy is the standard treatment for periampullary and pancreatic head carcinomas, with the high incidence of perioperative complications ranging from 40% to 60%. Malnutrition is a relevant predictor of post-operative morbidity and mortality after pancreatic surgery. Adequate nutrition is the key to reduce perioperative complications, including abdominal infection, poor healing of wounds, and even gastrointestinal anastomotic leak. The optimal nutritional support method after Pancreaticoduodenectomy is still uncertain, and the current nutritional support methods are diverse. The results of an international survey showed that there was very poor or no agreement on postoperative strategies for the management of nutrition after Pancreaticoduodenectomy. Therefore, the investigators designed this retrospective study to evaluate which was safer and more feasible between early oral feeding and nasojejunal early enteral nutrition after Pancreaticoduodenectomy, using the method of propensity score weighting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who underwent pancreaticoduodenectomy by a certain surgeon in Changhai Hospital

• Patients who were treated with nasojejunal enteral nutrition or oral enteral nutrition after operation.

Exclusion Criteria:

• Patients who underwent pancreaticoduodenectomy by other surgeons during the same period;

• Patients who received other nutritional support rather than nasojejunal tube enteral nutrition or oral enteral nutrition after operation.

Related Conditions & MeSH terms

• Pancreatoduodenectomy

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative complications	Complications defined by ISGPS in perioperative period	From Operation date to three months after operation