Early Oral Feeding for Patients After Pancreaticoduodenectomy

Completed

• Conditions: Pancreatoduodenectomy

• Registration Number: NCT05573399
• Lead Sponsor: Changhai Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-10
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-10
• Last Update Submitted: 2022-10-16
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative complications	From Operation date to three months after operation	Complications defined by ISGPS in perioperative period

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China