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Completed

NCT Number: NCT02142517

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

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.

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Key information

Conditions

Pancreatic Anastomotic Leak Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pancreatic Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayman El Nakeeb

Al Mansurah, Mansoura, 356111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Consecutive patients who were treated by pancreaticoduodenectomy

Exclusion criteria

  • 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
  • Coagulopathy

Treatment and study plan

Duct to mucosa PJ group

Procedure

Duct to mucosa PJ was performed by a two layer end to side PJ. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic duct diameter. The inner layer duct to mucosa was performed in eight to twelve stitches with 5/0 prolene. A pancreatic duct stent was inserted during anastomosis to allow easy and accurate suture placement, ensure adequate pancreatic duct exposure, and protect the opposite wall from being inadvertently held by needles then it was removed at the end of anastomosis.

Other names: Group 1

Invagination PJ group

Procedure

Invagination PJ was performed as an end to side. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic stump diameter. The inner layer was performed with 5/0 prolene between pancreatic parenchyma and mucosa. The duct was taken posteriorly and anteriorly to jejunal mucosa. A pancreatic duct stent was inserted during anastomosis and removed at the end of taking the stitches. Reconstruction was completed by end to side hepaticojejunostomy (retrocolic) and gastrojejunostomy (GJ) (antecolic) end to side manually.

Other names: Group 2

Primary outcomes

  1. 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

Secondary outcomes

  1. operative time

    Time frame: up to 10 hours

    time of surgical procedure

  2. hospital stay

    Time frame: up to 60 days

    postoperative stay

  3. postoperative complications

    Time frame: up to 90 days

    delayed gastric emptying (DGE), pancreatitis, biliary leakage

  4. 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 (

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: PJ

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 20, 2014
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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