Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy

Detailed Description
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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.

Official Title
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Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy
* Procedure: Invagination pancreaticojejunostomy


Participation Criteria
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Eligibility Criteria
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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。

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-layer duct-to-mucosa Group<br>Modified one-layer duct-to-mucosa pancreaticojejunostomy is used after pancreaticoduodenectomy. | Procedure: Modified one-layer duct-to-mucosa Pancreaticojejunostomy<br>* After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.<br>|
| Active Comparator: Invagination Group<br>Invagination pancreaticojejunostomy is used after pancreaticoduodenectomy. | Procedure: Invagination pancreaticojejunostomy<br>* After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinically relevant postoperative pancreatic fistula (POPF) | 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. | Up to 60 days after Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomosis time | Time from the beginning to the end of the pancreatic reconstruction | intraoperatively | 
| Delayed gastric emptying | 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. | Up to 60 day after Surgery | 
| post-pancreatectomy hemorrhage (PPH) | The 2017 International Study Group for Pancreatic Surgery definition and classification of PPH were applied. | Up to 60 days after Surgery | 
| Chyle leak | The 2017 International Study Group for Pancreatic Surgery definition and classification of chyle leak were applied. | Up to 60 days after Surgery | 
| Overall Morbidity | Any complications that occur postoperatively. The severity of complications was graded according to the Clavien-Dindo classification. | Up to 60 days after Surgery | 
| Mortality | Patient death that occurs postoperatively | Up to 90 days after Surgery | 
| Reoperation rate | Patients who needs a surgical re-operation for any reasons during the postoperative hosptial stay. Reasons and times of reoperation are recorded. | Up to 90 days after Surgery | 
| Readmission rate | Patients that readmitted into hospital for reasons that related to complications of last pancreatic surgery. | Up to 60 days after Surgery | 
| Duration of postoperative hospital stay | Time from day of operation to day of discharge | Up to 90 days after Surgery |