Pancreatic Head NeoplasmwhippleNCT06413888
Nasogastric Decompression Following Pancreaticoduodenectomy
A study testing pancreaticoduodenectomy in people with Pancreatic Head Neoplasm and Delayed Gastric Emptying, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Head Neoplasm, Delayed Gastric Emptying, Post Operative Ileus
- What is being tested?
- pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients 18 years of age or older
- Patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm.
Who cannot join
- Patients who does not complete the procedure due to locally advanced or metastatic disease discovered during the procedure.
- Patient who requires prolong postoperative intubation in the postoperative period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine Nasogastric Drainage vs. No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy: A Randomized Control Trial [NCT ID Not Yet Assigned]
Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period.
- Conditions
- Pancreatic Head Neoplasm, Delayed Gastric Emptying, Post Operative Ileus, Whipple Procedure
- Being tested
- pancreaticoduodenectomy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticoduodenectomyProcedure or surgery
Also called Whipple
Surgical removal of the head of the pancreas, duodenum, extrahepatic bile duct, distal stomach, and proximal jejunum. Group A cohort will not have NGT placed in the postoperative period. Whereas, group B will have the NGT retained in the posoperative period
| Study group | Role | What they receive |
|---|---|---|
| Group A ( No NGT) | Active comparator | Not described Receives: Procedure: pancreaticoduodenectomy |
| Group B (NGT Retained) | Active comparator | Not described Receives: Procedure: pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications
Severity of post operative complications was graded according to the Clavien-Dindo classification system adopted for pancreaic surgery, which relies on the type of treatment used for each complication with scores range from 1-4, and any complication graded >2 considered a major complication.
Measured: 30-days postoperatively
Secondary outcomes (2)
Examined the re-insertion rate of Nasogastric tube following pancreaticoduodenectomy
Patient will be considered to undergo nasogastric decompression with nasogastric tube if he/she demonstrated clinical evidence of postoperative ileus and delayed gastric emptying as defined according to the consensus definition proposed by the international study group of pancreatic surgery (ISGPS), the severity of which was classified into 3 grades (A,B, and C) based on clinical course and postoperative management such as the need nausea and vomiting and inability to tolerate solid oral intake by the end of the first postoperative week.
Measured: 30- days postoperatively
identify factors that necessitated its use in the immediate postoperative period
To identify preoperative factors such as obesity with BMI 30 or more, Preoperative uncontrolled diabtes, older age (over 70), gender (male/female), histroy of gastric outlet obstruction, primary diagnosis (malignant disease vs benign). Intra-operative factor such such as the length of the procedure, blood loss, any concurrent procedure such as extensive lysis of adhesions, colon resection; and postoperative factors including postoperative blood counts, phosphorus and magnesium levels, blood sugar level, and postoperative complications. These factors will be assessed using logistic regression analysis to predict the necessity of nasogastric decompression in the postoperative period following the whipple procedure.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jun 2018
- Primary completion31 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Head NeoplasmStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Model description
- Two groups of patients. Group 1 patients will have NGT placed in the operating room and continued in the immediate postoperative recovery period. Group 2 patients will have oropharyngeal gastric tube inserted in the operating room and removed at the end of the procedure.
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Barakat, Baylor College of Medicine
- Investigators
- Omar Barakat, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413888
- Sponsor's protocol ID
- H-43383
- Acronym
- whipple
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 14 May 2024
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Nasogastric Drainage vs. No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy: A Randomized Control Trial [NCT ID Not Yet Assigned]
- ClinicalTrials.gov ID
- NCT06413888
- Acronym / sponsor ID
- whipple / H-43383
- Conditions
- Pancreatic Head Neoplasm, Delayed Gastric Emptying, Post Operative Ileus, Whipple Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 May 2024 (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.
Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of patients. Group 1 patients will have NGT placed in the operating room and continued in the immediate postoperative recovery period. Group 2 patients will have oropharyngeal gastric tube inserted in the operating room and removed at the end of the procedure.
| Arm | Type | Receives |
|---|---|---|
| Group A ( No NGT) | Active comparator | Procedure: pancreaticoduodenectomy |
| Group B (NGT Retained) | Active comparator | Procedure: pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients 18 years of age or older
- Patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm.
Key exclusion criteria (2 listed)
- Patients who does not complete the procedure due to locally advanced or metastatic disease discovered during the procedure.
- Patient who requires prolong postoperative intubation in the postoperative period.
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 |
|---|---|---|
| pancreaticoduodenectomyAlso: WhippleSurgical removal of the head of the pancreas, duodenum, extrahepatic bile duct, distal stomach, and proximal jejunum. Group A cohort will not have NGT placed in the postoperative period. Whereas, group B will have the NGT retained in the posoperative period | Procedure or surgery | Group A ( No NGT), Group B (NGT Retained) |
Primary outcome
to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications
Time frame: 30-days postoperatively
Severity of post operative complications was graded according to the Clavien-Dindo classification system adopted for pancreaic surgery, which relies on the type of treatment used for each complication with scores range from 1-4, and any complication graded >2 considered a major complication.
2 secondary outcomes
Examined the re-insertion rate of Nasogastric tube following pancreaticoduodenectomy
Time frame: 30- days postoperatively
identify factors that necessitated its use in the immediate postoperative period
Time frame: 30 days postoperatively
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 14 May 2024.
- 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.
Omar Barakat, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreaticoduodenectomy in people with Pancreatic Head Neoplasm and Delayed Gastric Emptying, run by Baylor College of Medicine at 1 site in United States.
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 2 inclusion and 2 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 14 May 2024. 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 United States. 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?
to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications (time frame: 30-days postoperatively). 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 14 May 2024.