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

Not Applicable

Completed

• Conditions: Pancreatic Fistula; Pancreaticoduodenectomy; Complication of Surgical Procedure
• Interventions: Procedure: Without Trans-Nasal Afferent Loop Decompression; Procedure: Trans-Nasal Afferent Loop Decompression

• Registration Number: NCT04989868
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-04
• Study Start: 2021-08-06
• Primary Completion: 2022-11-12
• Study Completion: 2022-11-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Trans-Nasal Afferent Loop Decompression Arm	Without Trans-Nasal Afferent Loop Decompression	Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.
Trans-Nasal Afferent Loop Decompression Arm	Trans-Nasal Afferent Loop Decompression	Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.

Primary Outcome Measures

Name	Time	Method
Postoperative pancreatic fistula (grade B+C)	up to 90 days after surgery	Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.

Secondary Outcome Measures

Name	Time	Method
Overall complication and severe complication	up to 90 days after surgery	Overall complication (Clavien-Dindo ≥ grade I) and severe complication (Clavien-Dindo ≥ grade III)
Pancreatic fistula related complications	up to 90 days after surgery	Including intra-abdominal infection and intra-abdominal fluid accumulation
Reintervention treatment	up to 90 days after surgery	Number of patients with reintervention treatment for complications including percutaneous drainage, endoscopic procedure, angiographic procedure and reoperation
Other complications	up to 90 days after surgery	Including postoperative hemorrhage, delayed gastric emptying, chyle leak, bile leak, sepsis, incision complication, deep vein thrombosis, pulmonary embolism, etc
Mortality rate	up to 90 days after surgery	Death for any reason
Readmission	up to 90 days after surgery	New admission within 90-days of discharge from hospital for any reason
Postoperative new-onset pulmonary complication	up to 14 days after surgery	Including atelectasis, pleural effusion, pneumonitis
Length of postoperative stay	up to 90 days after surgery	From surgery to discharge including ICU stay

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China