Clinical trial NCT04989868: Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula
Official title: Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula: An Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Fistula
Pancreaticoduodenectomy
Complication of Surgical Procedure
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pancreatic fistula (grade B+C)
timeFrame: up to 90 days after surgery
Secondary outcomes:
measure: Pancreatic fistula related complications
timeFrame: up to 90 days after surgery
measure: Postoperative new-onset pulmonary complication
timeFrame: up to 14 days after surgery
measure: Other complications
timeFrame: up to 90 days after surgery
measure: Overall complication and severe complication
timeFrame: up to 90 days after surgery
measure: Reintervention treatment
timeFrame: up to 90 days after surgery
measure: Mortality rate
timeFrame: up to 90 days after surgery
measure: Length of postoperative stay
timeFrame: up to 90 days after surgery
measure: Readmission
timeFrame: up to 90 days after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jiang K Rong, MD
role: STUDY_DIRECTOR
References: