NCT05573399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

October 7, 2022

Last Update Submit

October 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perioperative complications

    Complications defined by ISGPS in perioperative period

    From Operation date to three months after operation

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent pancreaticoduodenectomy in Changhai Hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

  • Jing W, Wu S, Gao S, Shi X, Liu W, Ren Y, Ouyang L, Zheng K, Guo S, Wu C, Jin G. Early oral feeding versus nasojejunal early enteral nutrition in patients following pancreaticoduodenectomy: a propensity score-weighted analysis of 428 consecutive patients. Int J Surg. 2024 Jan 1;110(1):229-237. doi: 10.1097/JS9.0000000000000786.

Study Officials

  • Gang Jin, Doctor

    Changhai Hospital, Shanghai, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant of Hepatobiliary and Pancreatic Surgery

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 10, 2022

Study Start

August 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations