An interventional study of Trans-Nasal Afferent Loop Decompression and Without Trans-Nasal Afferent Loop Decompression in Pancreatic Fistula, Pancreaticoduodenectomy and Complication of Surgical Procedure, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
Postoperative pancreatic fistula (POPF) is a major complication and an important cause of mortality after pancreaticoduodenectomy (PD). Trans-nasal afferent loop decompression technique (TNALD) may reduce the rate of POPF based on our previous retrospective study. The aim of this open-label randomized controlled trial is to determine whether TNALD is a protective factor against the development of POPF after PD.
In our previous retrospective study, decompression of the afferent jejunal and pancreatic and biliary anastomoses with a special nasogastric tube and postoperative continuous closed negative pressure suction was shown to be associated with a reduction in overall POPF rate from 39% to 27% after PD. However, TNALD has the potential theoretical risk of increased morbidity including pulmonary complications and delayed gastric emptying.
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.
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's enrollment of 299 is above the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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Exclusion Criteria:
Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.
Procedure: Trans-Nasal Afferent Loop Decompression
Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.
Procedure: Without 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 decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
Postoperative pancreatic fistula (grade B+C)
Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.
Time frame: up to 90 days after surgery
Pancreatic fistula related complications
Including intra-abdominal infection and intra-abdominal fluid accumulation
Time frame: up to 90 days after surgery
Postoperative new-onset pulmonary complication
Including atelectasis, pleural effusion, pneumonitis
Time frame: up to 14 days after surgery
Other complications
Including postoperative hemorrhage, delayed gastric emptying, chyle leak, bile leak, sepsis, incision complication, deep vein thrombosis, pulmonary embolism, etc
Time frame: up to 90 days after surgery
Overall complication and severe complication
Overall complication (Clavien-Dindo ≥ grade I) and severe complication (Clavien-Dindo ≥ grade III)
Time frame: up to 90 days after surgery
Reintervention treatment
Number of patients with reintervention treatment for complications including percutaneous drainage, endoscopic procedure, angiographic procedure and reoperation
Time frame: up to 90 days after surgery
Mortality rate
Death for any reason
Time frame: up to 90 days after surgery
Length of postoperative stay
From surgery to discharge including ICU stay
Time frame: up to 90 days after surgery
Readmission
New admission within 90-days of discharge from hospital for any reason
Time frame: up to 90 days after surgery
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University