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

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.

Study Overview

• Status: Completed
• Conditions: Complication of Surgical Procedure; Pancreatic Fistula; Pancreaticoduodenectomy
• Intervention / Treatment: Procedure: Trans-Nasal Afferent Loop Decompression; Procedure: Without Trans-Nasal Afferent Loop Decompression

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 Type: Interventional
• Enrollment (Actual): 299
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital with Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trans-Nasal Afferent Loop Decompression Arm; Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.	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.
Active Comparator: No Trans-Nasal Afferent Loop Decompression Arm; Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Director: Jiang K Rong, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Actual): November 12, 2022
• Study Completion (Actual): November 12, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: TNALD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No