Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula (NCT04989868) | Clinical Trial Compass
CompletedNot Applicable
Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula
China299 participantsStarted 2021-08-06
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Patient scheduled for elective open pancreaticoduodenectomy with Child reconstruction
* Age \> 18 years and ≤ 85 years
* Full agreement to participate and written informed consent is given
Exclusion Criteria:
* Emergent pancreaticoduodenectomy
* 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
What they're measuring
1
Postoperative pancreatic fistula (grade B+C)
Timeframe: up to 90 days after surgery
Trial details
NCT IDNCT04989868
SponsorThe First Affiliated Hospital with Nanjing Medical University