NCT04989868

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

Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula: An Open-label Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pancreatic Fistula
• Pancreaticoduodenectomy
• Complication of Surgical Procedure

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2021-08-06
• Primary completion: 2022-11-12
• Completion: 2022-11-12
• First posted: 2021-08-04
• Last updated: 2023-08-08

Locations

1 site across 1 country: China