Pancreatic FistulaNCT04989868
Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula
A study testing Trans-Nasal Afferent Loop Decompression and Without Trans-Nasal Afferent Loop Decompression in people with Pancreatic Fistula and Pancreaticoduodenectomy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Fistula, Pancreaticoduodenectomy, Complication of Surgical Procedure
- What is being tested?
- Trans-Nasal Afferent Loop Decompression and Without Trans-Nasal Afferent Loop Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2021to 12 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: 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.
Read the 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.
- Being tested
- Trans-Nasal Afferent Loop Decompression, Without Trans-Nasal Afferent Loop Decompression
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-Nasal Afferent Loop DecompressionProcedure or surgery
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 DecompressionProcedure or surgery
No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
| Study group | Role | What they receive |
|---|---|---|
| Trans-Nasal Afferent Loop Decompression Arm | Experimental | Patients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy. Receives: 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. Receives: Procedure: Without Trans-Nasal Afferent Loop Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pancreatic fistula (grade B+C)
Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.
Measured: up to 90 days after surgery
Secondary outcomes (8)
Pancreatic fistula related complications
Including intra-abdominal infection and intra-abdominal fluid accumulation
Measured: up to 90 days after surgery
Postoperative new-onset pulmonary complication
Including atelectasis, pleural effusion, pneumonitis
Measured: 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
Measured: up to 90 days after surgery
Overall complication and severe complication
Overall complication (Clavien-Dindo ≥ grade I) and severe complication (Clavien-Dindo ≥ grade III)
Measured: 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
Measured: up to 90 days after surgery
Mortality rate
Death for any reason
Measured: up to 90 days after surgery
Length of postoperative stay
From surgery to discharge including ICU stay
Measured: up to 90 days after surgery
Readmission
New admission within 90-days of discharge from hospital for any reason
Measured: up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start6 Aug 2021
- Primary completion12 Nov 2022
- Study completion12 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuirong Jiang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Jiang K Rong, MD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989868
- Sponsor's protocol ID
- TNALD
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula: An Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04989868
- Acronym / sponsor ID
- TNALD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 12 Nov 2022 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-Nasal Afferent Loop Decompression Arm | Experimental | Procedure: Trans-Nasal Afferent Loop DecompressionPatients will receive trans-nasal afferent loop decompression after pancreaticoduodenectomy. |
| No Trans-Nasal Afferent Loop Decompression Arm | Active comparator | Procedure: Without Trans-Nasal Afferent Loop DecompressionPatients will NOT receive trans-nasal afferent loop decompression after pancreaticoduodenectomy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-Nasal Afferent Loop DecompressionA 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. | Procedure or surgery | Trans-Nasal Afferent Loop Decompression Arm |
| Without Trans-Nasal Afferent Loop DecompressionNo decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation. | Procedure or surgery | No Trans-Nasal Afferent Loop Decompression Arm |
Primary outcome
Postoperative pancreatic fistula (grade B+C)
Time frame: up to 90 days after surgery
Definition of postoperative pancreatic fistula was according ISGPS 2016 updates.
8 secondary outcomes
Pancreatic fistula related complications
Time frame: up to 90 days after surgery
Postoperative new-onset pulmonary complication
Time frame: up to 14 days after surgery
Other complications
Time frame: up to 90 days after surgery
Overall complication and severe complication
Time frame: up to 90 days after surgery
Reintervention treatment
Time frame: up to 90 days after surgery
Mortality rate
Time frame: up to 90 days after surgery
Length of postoperative stay
Time frame: up to 90 days after surgery
Readmission
Time frame: up to 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang K Rong, MD study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-Nasal Afferent Loop Decompression and Without Trans-Nasal Afferent Loop Decompression in people with Pancreatic Fistula and Pancreaticoduodenectomy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pancreatic fistula (grade B+C) (time frame: up to 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.