Early Oral Feeding for Patients After Pancreaticoduodenectomy

NCT ID: NCT05573399

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatoduodenectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guo ShiWei

Research Assistant of Hepatobiliary and Pancreatic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gang Jin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital, Shanghai, China

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37755371 (View on PubMed)

Other Identifiers

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ChanghaiH-PP11

Identifier Type: -

Identifier Source: org_study_id

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