One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy
1 other identifier
interventional
114
1 country
1
Brief Summary
The aim of this study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "One-layer duct-to-mucosa pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 30, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 18, 2015
August 1, 2015
3.3 years
July 23, 2015
August 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pancreatic fistula(POPF) rate
drainage of any measurable volume of fluid with an amylase content \>3 times the upper normal serum value on or after postoperative day 3.
30 days
Secondary Outcomes (7)
Duration of postoperative hospital stay
30 days
anastomosis time
1 hour
reoperation rate
30 days
Morbidity
30 days
Mortality
30 days
- +2 more secondary outcomes
Study Arms (2)
one-layer duct-to-mucosa anastomosis
EXPERIMENTALone-layer duct-to-mucosa anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
two-layer duct-to-mucosa anastomosis
ACTIVE COMPARATORtwo-layer duct-to-mucosa anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
Interventions
To create the posterior suturing layers, the needle is inserted from the posterior interior side of the pancreatic duct, passing through the dorsal region of the parenchyma of the pancreatic stump to the posterior surface of the pancreas approximately 0.5 cm distal to the cut edge. The other side of the needle starts from the inside of the jejunum lumen to the subserosa and then passes through the seromuscular layer to the posterior surface of the bowel.The anterior suturing layer is performed in the same manner. 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.
Eligibility Criteria
You may qualify if:
- Both male and female, aged 18 to 80;
- Patients scheduled to undergo pancreaticoduodenectomy;
- Provided written informed consent;
You may not qualify if:
- Patients with severe cardiopulmonary disorder that might prolong the postoperative hospital stay;
- Patients who had a previous pancreatic operation;
- Patients with an immunodeficiency;
- Patients who underwent an emergency operation;
- Pregnant patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Related Publications (4)
Zhang L, Li Z, Wu X, Li Y, Zeng Z. Sealing pancreaticojejunostomy in combination with duct parenchyma to mucosa seromuscular one-layer anastomosis: a novel technique to prevent pancreatic fistula after pancreaticoduodenectomy. J Am Coll Surg. 2015 May;220(5):e71-7. doi: 10.1016/j.jamcollsurg.2014.12.047. Epub 2015 Jan 15. No abstract available.
PMID: 25840535RESULTWei 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. doi: 10.9738/INTSURG-D-15-00094.1. Online ahead of print.
PMID: 26037262RESULTEl Nakeeb A, El Hemaly M, Askr W, Abd Ellatif M, Hamed H, Elghawalby A, Attia M, Abdallah T, Abd ElWahab M. Comparative study between duct to mucosa and invagination pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized study. Int J Surg. 2015 Apr;16(Pt A):1-6. doi: 10.1016/j.ijsu.2015.02.002. Epub 2015 Feb 13.
PMID: 25682724RESULTPan SB, Geng W, Zhou DC, Chen JM, Zhao HC, Liu FB, Xie SX, Hou H, Zhao YJ, Xie K, Wang GB, Geng XP. One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial. Trials. 2016 Aug 17;17(1):407. doi: 10.1186/s13063-016-1517-8.
PMID: 27530630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
xiaoping geng, professor
the vice President of the second affiliated hospitalof Anhui medical university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice-president
Study Record Dates
First Submitted
July 23, 2015
First Posted
July 30, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
August 18, 2015
Record last verified: 2015-08