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

Complication of Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989868
• Other study ID #: TNALD
• Status: Completed
• Phase: N/A
• Start date: August 6, 2021
• Est. completion date: November 12, 2022

Study information

• Verified date: August 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: November 12, 2022
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Fistula
• Pancreatic Fistula
• Pancreaticoduodenectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pancreatic fistula (grade B+C)	Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.	up to 90 days after surgery
Secondary	Pancreatic fistula related complications	Including intra-abdominal infection and intra-abdominal fluid accumulation	up to 90 days after surgery
Secondary	Postoperative new-onset pulmonary complication	Including atelectasis, pleural effusion, pneumonitis	up to 14 days after surgery
Secondary	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
Secondary	Overall complication and severe complication	Overall complication (Clavien-Dindo = grade I) and severe complication (Clavien-Dindo = grade III)	up to 90 days after surgery
Secondary	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
Secondary	Mortality rate	Death for any reason	up to 90 days after surgery
Secondary	Length of postoperative stay	From surgery to discharge including ICU stay	up to 90 days after surgery
Secondary	Readmission	New admission within 90-days of discharge from hospital for any reason	up to 90 days after surgery