Pancreatic Fistula
Conditions
Brief summary
The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy
Detailed description
Duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy, with comparable incidence rate of pancreatic fistula (PF). We modified the conventional two-layer duct-to-mucosa PJ into one-layer PJ. The aim of this study is to examine if the investigator's modified duct-to-mucosa PJ can reduce PF after PD when compared to invagination PJ. This trial is a single-center, randomized, controlled, patient- and observer- blinded study, whose primary aim is to assess whether a modified duct-to-mucosa PJ (trial group) is superior to an invagination PJ (control group), in terms of clinically relevant PF and other complications. A total of 380 patients, who are to undergo elective PD, will be recruited and randomized intraoperatively into either of the two groups. The primary efficacy endpoint is the incident rate of clinically relevant PF. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay. Patients will be followed up for 3 months. Statistical analysis will be based on the intention-to-treat population. The duration of the entire trial is estimated to be two years.
Interventions
PROCEDUREModified one-layer duct-to-mucosa Pancreaticojejunostomy
After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.
PROCEDUREInvagination pancreaticojejunostomy
After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Written Informed consent obtained； * Both sexes between 18 and 80 years old； * Patients scheduled to elective open pancreaticoduodenectomy.
Exclusion criteria
* Patients with ASA score \>=4; * Patients who had a previous pancreatic operation; * Patients with an immunodeficiency; * Patients who underwent an emergency operation; * Pregnant patients； * Patients who was found that pancreaticoduodenectomy was not suitable。
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinically relevant postoperative pancreatic fistula (POPF) | Up to 60 days after Surgery | As defined by International Study Group on Pancreatic Fistula, a clinically relevant postoperative pancreatic fistula is now redefined as a drain output of any measurable volume of fluid with an amylase level \>3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delayed gastric emptying | Up to 60 day after Surgery | The International Study Group for Pancreatic Surgery definition and classification of delayed gastric emptying were applied. Briefly, grade A, unable to tolerate solid oral intake by POD 7 and usually no vomiting; grade B, unable to tolerate solid oral intake by POD 14 with/without vomiting: and grade C, unable to tolerate solid oral intake by POD 21 with/without vomiting. |
| post-pancreatectomy hemorrhage (PPH) | Up to 60 days after Surgery | The 2017 International Study Group for Pancreatic Surgery definition and classification of PPH were applied. |
| Chyle leak | Up to 60 days after Surgery | The 2017 International Study Group for Pancreatic Surgery definition and classification of chyle leak were applied. |
| Overall Morbidity | Up to 60 days after Surgery | Any complications that occur postoperatively. The severity of complications was graded according to the Clavien-Dindo classification. |
| Anastomosis time | intraoperatively | Time from the beginning to the end of the pancreatic reconstruction |
| Reoperation rate | Up to 90 days after Surgery | Patients who needs a surgical re-operation for any reasons during the postoperative hosptial stay. Reasons and times of reoperation are recorded. |
| Readmission rate | Up to 60 days after Surgery | Patients that readmitted into hospital for reasons that related to complications of last pancreatic surgery. |
| Duration of postoperative hospital stay | Up to 90 days after Surgery | Time from day of operation to day of discharge |
| Mortality | Up to 90 days after Surgery | Patient death that occurs postoperatively |
Countries
China
Contacts
Primary ContactJishu Wei, M.D.
Outcome results
None listed