Early Oral Feeding for Patients After Pancreaticoduodenectomy

Sponsor
Changhai Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05573399
Collaborator
(none)
440
1
41
10.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    440 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Efficacy Analysis on Early Oral Feeding Versus Nasojejunal Early Enteral Nutrition for Patients After Pancreaticoduodenectomy
    Actual Study Start Date :
    Aug 1, 2018
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Early oral feeding

    No enteral feeding tube was placed after pancreaticoduodenectomy and oral nutrition was given early. Patients were given liquid drinks on the second day after pancreaticoduodenectomy, and solid food from the fifth day.

    Early nasojejunal enteral nutrition

    Early enteral nutrition was given early through nasojejunal tube. 5% glucose saline was given on the first day after pancreaticoduodenectomy through nasojejunal tube. Enteral nutrition was given from the second day after pancreaticoduodenectomy. When oral intake was adequate, the nasojejunal tube was removed on the sixth day.

    Outcome Measures

    Primary Outcome Measures

    1. Perioperative complications [From Operation date to three months after operation]

      Complications defined by ISGPS in perioperative period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Changhai Hospital Shanghai Shanghai China

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

    • Principal Investigator: Gang Jin, Doctor, Changhai Hospital, Shanghai, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guo ShiWei, Research Assistant of Hepatobiliary and Pancreatic Surgery, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT05573399
    Other Study ID Numbers:
    • ChanghaiH-PP11
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Oct 18, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 18, 2022