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

Primary Purpose

Pancreatic Fistula, Pancreaticoduodenectomy, Complication of Surgical Procedure

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Trans-Nasal Afferent Loop Decompression

Without Trans-Nasal Afferent Loop Decompression

About this trial

This is an interventional treatment trial for Pancreatic Fistula

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The First Affiliated Hospital with Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trans-Nasal Afferent Loop Decompression Arm

No Trans-Nasal Afferent Loop Decompression Arm

Arm Description

Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.

Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.

Outcomes

Primary Outcome Measures

Postoperative pancreatic fistula (grade B+C)

Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.

Secondary Outcome Measures

Pancreatic fistula related complications

Including intra-abdominal infection and intra-abdominal fluid accumulation

Postoperative new-onset pulmonary complication

Including atelectasis, pleural effusion, pneumonitis

Other complications

Including postoperative hemorrhage, delayed gastric emptying, chyle leak, bile leak, sepsis, incision complication, deep vein thrombosis, pulmonary embolism, etc

Overall complication and severe complication

Overall complication (Clavien-Dindo ≥ grade I) and severe complication (Clavien-Dindo ≥ grade III)

Reintervention treatment

Number of patients with reintervention treatment for complications including percutaneous drainage, endoscopic procedure, angiographic procedure and reoperation

Mortality rate

Death for any reason

Length of postoperative stay

From surgery to discharge including ICU stay

Readmission

New admission within 90-days of discharge from hospital for any reason

Full Information

NCT ID

NCT04989868

First Posted

July 27, 2021

Last Updated

August 6, 2023

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04989868

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

August 6, 2021 (Actual)

Primary Completion Date

November 12, 2022 (Actual)

Study Completion Date

November 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Fistula, Pancreaticoduodenectomy, Complication of Surgical Procedure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

299 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trans-Nasal Afferent Loop Decompression Arm

Arm Type

Experimental

Arm Description

Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.

Arm Title

No Trans-Nasal Afferent Loop Decompression Arm

Arm Type

Active Comparator

Arm Description

Patients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy.

Intervention Type

Procedure

Intervention Name(s)

Trans-Nasal Afferent Loop Decompression

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Without Trans-Nasal Afferent Loop Decompression

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative pancreatic fistula (grade B+C)

Description

Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.

Time Frame

up to 90 days after surgery

Secondary Outcome Measure Information:

Title

Pancreatic fistula related complications

Description

Including intra-abdominal infection and intra-abdominal fluid accumulation

Time Frame

up to 90 days after surgery

Title

Postoperative new-onset pulmonary complication

Description

Including atelectasis, pleural effusion, pneumonitis

Time Frame

up to 14 days after surgery

Title

Other complications

Description

Including postoperative hemorrhage, delayed gastric emptying, chyle leak, bile leak, sepsis, incision complication, deep vein thrombosis, pulmonary embolism, etc

Time Frame

up to 90 days after surgery

Title

Overall complication and severe complication

Description

Overall complication (Clavien-Dindo ≥ grade I) and severe complication (Clavien-Dindo ≥ grade III)

Time Frame

up to 90 days after surgery

Title

Reintervention treatment

Description

Number of patients with reintervention treatment for complications including percutaneous drainage, endoscopic procedure, angiographic procedure and reoperation

Time Frame

up to 90 days after surgery

Title

Mortality rate

Description

Death for any reason

Time Frame

up to 90 days after surgery

Title

Length of postoperative stay

Description

From surgery to discharge including ICU stay

Time Frame

up to 90 days after surgery

Title

Readmission

Description

New admission within 90-days of discharge from hospital for any reason

Time Frame

up to 90 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiang K Rong, MD

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Study Director

Facility Information:

Facility Name

The First Affiliated Hospital with Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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