Clinical trial NCT02941484: Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS
Official title: A Prospective, Randomized Trial of Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periampullary Carcinoma Resectable
Pancreaticoduodenectomy
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2016-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the ERAS guideline, which was based on studies in patients with gastrointestinal cancer, mainly colorectal and gastric. Specific clinical study on early oral intake after PD is very limited. inadequate nutritional intake was significantly associated with a high incidence of postoperative complications. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Detailed description: Enhanced Recovery After Surgery (ERAS) is an interdisciplinary, multimodal concept and has become an important focus of Pancreaticoduodenectomy procedures following universal accepted and practice in gastrointestinal and colorectal surgeries. Early oral diet without restrictions after operation is recommended strongly according to ERAS guideline. However, several studies demonstrated that only half validated the true practice of the postoperative oral diet. Furthermore, Oral intake tolerance after PD is controversial. Only 23% of patients were able to take solid food at day 3. It appears that adequate nutritional intake only via oral diet is a severe challenge. Besides, Studies showed that insufficient amount of dietary intake was significantly associated with extended duration of postoperative hospitalization and parenteral nutrition. Importantly, Specific clinical study on early oral intake after PD is very limited. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Eligibility criteria: Inclusion Criteria:

* Periampullar carcinoma
* Pancreaticoduodenectomy
* ERAS protocol implemented

Exclusion Criteria:

* Preoperative Radiotherapy/chemotherapy
* Unresectable primary cancer
* Palliative surgery
* New York Heart Association class\>3

Primary outcomes:
measure: Tolerance of Oral Intake
timeFrame: postoperative 1 to 7day
Secondary outcomes:
measure: morbidity rate
timeFrame: postoperative 1day to discharge, up to 8 weeks
measure: length of stay
timeFrame: postoperative 1day to discharge,up to 8 weeks
measure: Readmission rate
timeFrame: 30 days after discharge
measure: Hospital costs
timeFrame: postoperative 1day to discharge,up to 8 weeks
measure: Albumin
timeFrame: postoperative 30d
measure: weight
timeFrame: postoperative 30d
measure: height
timeFrame: postoperative 30d
Other outcomes:
Locations:
city: Suqian
country: China
facility: Suqian Hospital
state: Jiangsu
Study officials:
affiliation: Suqian Hospital
name: zheng chen, MD;PHD
role: PRINCIPAL_INVESTIGATOR
References:
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