Clinical Trial: Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy:

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy: A Prospective Randomized Study

Brief Summary: Postoperative pancreatic fistula (POPF) remains a challenge even at specialized centers, and also affect significantly the surgical outcomes . The incidence of POPF after pancreaticoduodenectomy among different studies, ranging from 5 to 30%.Morbidity and mortality after pancreaticoduodenectomy are usually related to surgical management of the pancreatic stump. The safe pancreatic reconstruction after pancreaticoduodenectomy continues to be a challenge at high volume centers. The variety of reconstruction is a reflection of the lack of ideal one.Duct to mucosa and invagination are two classic PJ techniques. Many studies compared both techniques, but their surgical outcomes still unclear.The aim of the study was to assess the effectiveness and surgical outcomes of both techniques of PJ after pancreaticoduodenectomy.

Detailed Summary:

Consecutive patients who were treated by pancreaticoduodenectomy at Gastroenterology Surgical Center, Mansoura, Egypt Exclusion criteria included any patients with locally advanced periampullary tumour, metastases, patients received neoadjuvant chemoradiotherapy, patients underwent pancreaticogastrostomy (PG), patients with advanced liver cirrhosis (Child B or C), malnutrition, or coagulopathy.

All patients were subjected to careful history taking, clinical examination, routine laboratory investigation abdominal ultrasound, magnetic resonance cholangiopancreatography , and abdominal computerized tomography .

The patients were randomized into two groups: Group I: patients underwent duct to mucosa PJ. Group II: patients underwent invagination PJ.

The primary outcome was POPF rate.Secondary outcomes were operative time, operative time needed for reconstruction, length of postoperative hospital stay, postoperative morbidities


Sponsor: Mansoura University

Current Primary Outcome: POPF [ Time Frame: up to 30 days ]

POPF was defined by International Study Group of Pancreatic Fistula (ISGPF) as any measurable volume of fluid on or after POD 3 with amylase content greater than 3 times the serum amylase activity . A pancreatic fistula (PF) were graded according to the ISGPF into Grade A, B, and C according to the clinical course


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • operative time [ Time Frame: up to 10 hours ]
    time of surgical procedure
  • hospital stay [ Time Frame: up to 60 days ]
    postoperative stay
  • postoperative complications [ Time Frame: up to 90 days ]
    delayed gastric emptying (DGE), pancreatitis, biliary leakage
  • Pancreatic function [ Time Frame: up to one year ]
    Pancreatic exocrine function was evaluated clinically. It was assessed by presence or absence of steatorrhae (more than three stool per day, fecal output of > 200 g/d for at least three days, pale or yellow stools, and appearance of stools as pasty or greasy, the need of pancreatic enzymes supplement and studied variation in body weight pre and postoperative (


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: May 16, 2014
Date Started: June 2011
Date Completion:
Last Updated: May 19, 2014
Last Verified: June 2011