NCT04989868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

August 6, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2022

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

July 27, 2021

Last Update Submit

August 6, 2023

Conditions

Pancreatic FistulaPancreaticoduodenectomyComplication of Surgical Procedure

Outcome Measures

Primary Outcomes (1)

  • Postoperative pancreatic fistula (grade B+C)

    Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.

    up to 90 days after surgery

Secondary Outcomes (8)

  • Pancreatic fistula related complications

    up to 90 days after surgery

  • Postoperative new-onset pulmonary complication

    up to 14 days after surgery

  • Other complications

    up to 90 days after surgery

  • Overall complication and severe complication

    up to 90 days after surgery

  • Reintervention treatment

    up to 90 days after surgery

  • +3 more secondary outcomes

Study Arms (2)

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

Trans-Nasal Afferent Loop DecompressionPROCEDURE

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.

Trans-Nasal Afferent Loop Decompression Arm
Without Trans-Nasal Afferent Loop DecompressionPROCEDURE

No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.

No Trans-Nasal Afferent Loop Decompression Arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jiang K Rong, MD

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pancreas Center

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 4, 2021

Study Start

August 6, 2021

Primary Completion

November 12, 2022

Study Completion

November 12, 2022

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)