Effect of Trans-Nasal Afferent Loop Decompression on Post... | NCT04989868

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

NCT04989868

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Completed

Last Update Posted

Aug 8, 2023Actual

Enrollment

299Actual

Phase

Not Applicable

Conditions

Pancreatic Fistula
Pancreaticoduodenectomy
Complication of Surgical Procedure

Interventions

Trans-Nasal Afferent Loop Decompression
Without Trans-Nasal Afferent Loop Decompression

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2021Actual

Primary Completion Date

Nov 12, 2022Actual

Completion Date

Nov 12, 2022Actual

First Submitted Date

Jul 27, 2021

First Submission Date that Met QC Criteria

Jul 28, 2021

First Posted Date

Aug 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2023

Last Update Posted Date

Aug 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kuirong Jiang, Director of Pancreas Center, The First Affiliated Hospital with Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

299Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trans-Nasal Afferent Loop Decompression Arm	Experimental	Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.	Procedure: Trans-Nasal Afferent Loop Decompression
No Trans-Nasal Afferent Loop Decompression Arm	Active Comparator	Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.	Procedure: Without Trans-Nasal Afferent Loop Decompression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trans-Nasal Afferent Loop Decompression	Procedure	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jiang K Rong, MD	The First Affiliated Hospital with Nanjing Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital with Nanjing Medical University		Nanjing	Jiangsu	210029	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D005402	Fistula
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms