Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula
NCT ID: NCT04989868
Last Updated: 2023-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
299 participants
INTERVENTIONAL
2021-08-06
2022-11-12
Brief Summary
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Detailed Description
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The objective of this prospective randomized study is to evaluate the impact of trans-nasal afferent loop decompression on the incidence of complications after PD, especially POPF rate according to International Study Group of Pancreatic Surgery (ISGPS) 2016 updates. We hypothesize that the TNALD may prevent the development of POPF after PD. This study randomizes patients to TNALD versus no TNALD group. Subgroup analysis of the outcomes in different POPF risk groups is also planned.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trans-Nasal Afferent Loop Decompression Arm
Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.
Trans-Nasal Afferent Loop Decompression
A 14Fr silicon tube with multiple side holes within the range of 15 cm from the tip will be placed into the afferent jejunal limb with its end close to the pancreaticojejunostomy (\<3 cm) during the surgery. Continuous closed negative-pressure suction will be applied to that tube for 72 hours and after that the nasogastric tube will be removed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
No Trans-Nasal Afferent Loop Decompression Arm
Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.
Without Trans-Nasal Afferent Loop Decompression
No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
Interventions
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Trans-Nasal Afferent Loop Decompression
A 14Fr silicon tube with multiple side holes within the range of 15 cm from the tip will be placed into the afferent jejunal limb with its end close to the pancreaticojejunostomy (\<3 cm) during the surgery. Continuous closed negative-pressure suction will be applied to that tube for 72 hours and after that the nasogastric tube will be removed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
Without Trans-Nasal Afferent Loop Decompression
No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years and ≤ 85 years
* Full agreement to participate and written informed consent is given
Exclusion Criteria
* Laparoscopic pancreaticoduodenectomy or robotic pancreaticoduodenectomy, including transition to open approach
* Participant in other trials of pancreaticoduodenectomy with interfering interventions and/or endpoints
* Patient with severe co-morbidity(s) before surgery, including severe insufficiency in kidney, heart and/or liver, etc.
* Patient had medication history of corticosteroids over 3 days during last 30 days before surgery
* No need for pancreaticojejunostomy during pancreaticoduodenectomy (i.e. past left pancreatectomy, pancreaticogastrostomy, etc.), or pancreatic anastomosis cannot be reconstructed for any reason
* External stenting is used during the surgery for any reason
* Nasogastric tube is inserted and kept for postoperative gastric decompression
* In any situation that the placement of afferent loop decompression tube is medically inappropriate or not infeasible
18 Years
85 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Kuirong Jiang
Director of Pancreas Center
Principal Investigators
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Jiang K Rong, MD
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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TNALD
Identifier Type: -
Identifier Source: org_study_id
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