Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula

  • STATUS
    Recruiting
  • End date
    Jan 19, 2023
  • participants needed
    484
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 19 August 2021

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.

Description

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.

Details
Condition Pancreatic disorder, Pancreatic Fistula, Pancreaticoduodenectomy, Complication of Surgical Procedure, whipple procedure
Treatment Trans-Nasal Afferent Loop Decompression, Without Trans-Nasal Afferent Loop Decompression
Clinical Study IdentifierNCT04989868
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

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
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