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Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

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ClinicalTrials.gov Identifier: NCT01731821
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

Study Description
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Brief Summary:
Pancreaticojejunostomy is the key procedure of pancreaticoduodenectomy. The aim of our study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "nonstented stump-closed pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Biliary Tract Neoplasms Pancreatitis, Chronic Duodenal Neoplasms Procedure: pancreaticojejunostomy Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy
Study Start Date : October 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Nonstented stump-closed anastomosis
Nonstented stump-closed anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
 Procedure: pancreaticojejunostomy

Nonstented stump closed pancreaticojejunostomy:

Close the pancreatic stump with interrupted inverting sutures around the "papillary-like" pancreatic duct.

A small full-thickness enterotomy was penetrated on the jejunal wall for connecting to the "papillary-like" pancreatic duct by placing 4-6 sutures from the "periductal" parenchyma to the whole-layer jejunum hole. After that, interrupted sutures between the front wall of pancreatic stump and the seromuscular jejunum were performed by 4-0 absorbable sutures to complete the anastomosis.

Duct-to-mucosa pancreaticojejunostomy:Two layer anatomosis with "Duct-to-Mucosa" pancreaticojejunostomy is performed by suturing the pancreatic parenchyma to the jejunal seromuscular layer and no stenting tube was used.
Active Comparator: Duct-to-mucosa anastomosis
Duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy.
 Procedure: pancreaticojejunostomy

Nonstented stump closed pancreaticojejunostomy:

Close the pancreatic stump with interrupted inverting sutures around the "papillary-like" pancreatic duct.

A small full-thickness enterotomy was penetrated on the jejunal wall for connecting to the "papillary-like" pancreatic duct by placing 4-6 sutures from the "periductal" parenchyma to the whole-layer jejunum hole. After that, interrupted sutures between the front wall of pancreatic stump and the seromuscular jejunum were performed by 4-0 absorbable sutures to complete the anastomosis.

Duct-to-mucosa pancreaticojejunostomy:Two layer anatomosis with "Duct-to-Mucosa" pancreaticojejunostomy is performed by suturing the pancreatic parenchyma to the jejunal seromuscular layer and no stenting tube was used.


Outcome Measures
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Primary Outcome Measures :
  1. the postoperative pancreatic fistula(POPF) rate [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. postoperative hospital stay time; [ Time Frame: 90 days ]
  2. anastomosis time; [ Time Frame: 1 hour ]
  3. reoperation rate; [ Time Frame: 30 days ]
  4. morbidity and mortality [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • 18-80 years old;
  • Eastern Cooperative Oncology Group(ECOG) 0-2
  • Patients must have undergone pancreaticoduodenectomy.
  • Preoperative enhanced CT scan shows respectable or borderline resectable neoplasm
  • Without distal metastasis

Exclusion Criteria:

  • Patients who have had previous pancreatic body tail resection rese
  • immunodeficiency, people infected with HIV
  • patients with severe cardiopulmonary function, liver and renal function
  • infection without control or active infections
  • Pregnant patients.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731821


Locations
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Xian-Jun Yu, M.D. Department of Pancreatic & Hepatobiliary Surgery
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Xian-Jun Yu, Professor and Chair,Department of Pancreatic & Hepatobiliary Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT01731821     History of Changes
Other Study ID Numbers: PCI001
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Xian-Jun Yu, Fudan University:
Pancreaticoduodenectomy
Pancreaticojejunostomy

Additional relevant MeSH terms:
Neoplasms
Pancreatitis
Pancreatic Neoplasms
Biliary Tract Neoplasms
Pancreatitis, Chronic
Duodenal Neoplasms
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
 Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Biliary Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases