Pancreaticoduodenectomy, Periampullary Carcinoma Resectable
Conditions
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.
Interventions
PROCEDUREearly oral intake
early oral intake is started within 24 hours after pancreaticoduodenectomies following to the ERAS guideline
PROCEDUREjejunostomy tube feeding (JTF)
The jejunostomy tube was placed using the Flocare CH-10 tube with the longitudinal Witzel jejunostomy technique.nutrition is supplemented via JTF rather than early oral intake.Velocity is progressively increased by 20ml/hr until full nutritional goal (25Kcal/Kg)
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Periampullar carcinoma * Pancreaticoduodenectomy * ERAS protocol implemented
Exclusion criteria
* Preoperative Radiotherapy/chemotherapy * Unresectable primary cancer * Palliative surgery * New York Heart Association class\>3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of Oral Intake | postoperative 1 to 7day | the amount of oral intake is recorded, including clear fluids, soft and solid food. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of stay | postoperative 1day to discharge,up to 8 weeks | postoperative length of stay |
| Readmission rate | 30 days after discharge | — |
| Hospital costs | postoperative 1day to discharge,up to 8 weeks | — |
| morbidity rate | postoperative 1day to discharge, up to 8 weeks | complications associated with surgery, early oral intake,and jejunostomy tube.Definitions used for specific complications are according to the International Study Group on Pancreatic Fistula (ISGPF) definition. |
| weight | postoperative 30d | weight in kilograms |
| height | postoperative 30d | height in meters |
| Albumin | postoperative 30d | serum albumin |
Countries
China
Contacts
Primary Contactzheng chen, MD;PHD
Backup Contactwanli liu, MD
Outcome results
None listed