Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03600584
• Other study ID #: JSPH-PC-201801
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: March 2020

Study information

• Verified date: July 2018
• Source: Nanjing Medical University
• Contact: Jishu Wei, M.D.
• Phone: 86-25-68136891
• Email: weijishu[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 380
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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?

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Procedure:
• Modified 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.
• Invagination pancreaticojejunostomy
After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Wei J, Liu X, Wu J, Xu W, Zhou J, Lu Z, Chen J, Guo F, Gao W, Li Q, Jiang K, Dai C, Miao Y. Modified One-layer Duct-to-mucosa Pancreaticojejunostomy Reduces Pancreatic Fistula After Pancreaticoduodenectomy. Int Surg. 2015 Jun 3. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anastomosis time	Time from the beginning to the end of the pancreatic reconstruction	intraoperatively
Secondary	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
Secondary	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
Secondary	Chyle leak	The 2017 International Study Group for Pancreatic Surgery definition and classification of chyle leak were applied.	Up to 60 days after Surgery
Secondary	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
Secondary	Mortality	Patient death that occurs postoperatively	Up to 90 days after Surgery
Secondary	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
Secondary	Readmission rate	Patients that readmitted into hospital for reasons that related to complications of last pancreatic surgery.	Up to 60 days after Surgery
Secondary	Duration of postoperative hospital stay	Time from day of operation to day of discharge	Up to 90 days after Surgery