PancreaticoduodenectomyNCT05314244
Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Delayed Gastric Emptying and Nutrition
A study testing Pylorus resecting pancreaticoduodenectomy in people with Pancreaticoduodenectomy and Delayed Gastric Emptying, run by Asan Medical Center.
Trial summary
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreaticoduodenectomy, Delayed Gastric Emptying, Nutrition
- What is being tested?
- Pylorus resecting pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 28 Apr 2025
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 79 years
- Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
- The preoperative examination showed that the lesion could invade to major artery.
- No distant metastasis
- Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3
- Liver function : aspartate transaminase (AST)/alanine transaminase(ALT) less than 3 times upper limit of normal
- Kidney function: Creatinine no greater than 1.5 times upper limit of normal.
- Patients who consented to and signed the consent
Who cannot join
- Patients diagnosed with duodenal cancer
- Those with active or uncontrolled infections
- Those with severe psychiatric / neurological disorders
- Alcohol or other drug addicts
- Patients who underwent previous major abdominal surgery (ex. gastrectomy, colectomy)
- Patients included in other clinical studies that may affect this study
Show all 12Show fewer
- Patients who cannot follow the directions of the researcher
- Those with uncontrolled heart disease
- Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (ex. cirrhosis, chronic kidney failure, heart failure, etc.)
- Pelvic tumor, benign tumor, malignant tumor in other organs
- Patients who received prior chemotherapy
- In addition to the planned pancreaticoduodenectomy, patients who require resection of other major abdominal organs, such as gastrectomy, colectomy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Postoperative Delayed Gastric Emptying and Nutritional Status
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. Recently, pylorus resecting pancreaticoduodenectomy has been actively performed because some studies reported that the procedure can reduce postoperative delayed gastric emptying.
However, the level of evidence is low and there was few studies considering nutritional status after pylorus resecting pancreaticoduodenectomy.
The purpose of this study is to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status.
Read the detailed description
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. It can lead to delay initiation of adjuvant chemotherapy as well as postoperative recovery. Since 2010, pylorus resecting pancreaticoduodenectomy was introduced to reduce postoperative delayed gastric emptying. The cases have been actively increased. However, several prospective randomized controlled trials reported pylorus resection during pancreaticoduodenectomy did not reduce the incidence or severity of delayed gastric emptying. Recent meta-analysis also showed same results.
Previous randomized controlled trials were single center studies participating a relatively small number of patients. A large-scale multicenter study is needed to obtain high level of evidence. And nutritional difference may appear between pylorus preservation and resection groups. Few studies have dealt with nutritional status between two groups.
- This study aimed to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status in 5 tertiary referral centers in Korea..
- A case of pancreaticoduodenectomy with periampullary benign and malignant tumors will be included. The expected number of patients is 394. The pylorus resecting group was performed in the experimental group and the pylorus preserving group was performed in control group.
This clinical study is a randomized prospective comparative study of the outcome of pylorus resecting and preserving pancreatoduodenectomy, and the research hypothesis is as follows.
- Nursing Hypothesis: There is no difference in incidence of delayed gastric emptying between patients who underwent pylorus resecting pancreaticoduodenectomy and patients who underwent pylorus preserving surgery.
- Alternative Hypothesis: Based on the results of the same operation of the existing institution, the average incidence of delayed gastric emptying for pylorus preserving pancreaticoduodenectomy is estimated to be 20%, and the average incidence of delayed gastric emptying for pylorus resecting pancreaticoduodenectomy is estimated to be 10%.
The random assignment of this study is assigned according to the order of assignment in the planning stage of the study as a block randomization scheme with appropriate block size set.
- Plan for recruitment of research subjects : All patients scheduled for open pancreaticoduodenectomy for pancreatic or periampullary lesions will be explained about this study and will be selected after informed consent.
- Operative method : Both patients underwent conventional open pancreaticoduodenectomy with or without pylorus resection. In the experimental group, stomach resection was performed 1.0cm proximal to pylorus. In the control group, duodenal resection was performed 2.0cm distal to pylorus. Both groups are performed through the same surgical procedure except pylorus preservation or resection and the procedure is as follows. Kocher maneuver is performed to mobilize the duodenum. Omentectomy is performed and the gastrocolic truck is identified and ligated. The stomach or duodenum is cut off using an automatic stapler. A cholecystectomy is performed. The bile duct is cut and the frozen section is checked to confirm whether the tumor is invaded. The hepatic and hepatic arteries are dissected and the surrounding lymph nodes are dissected. The gastroduodenal artery is detached and ligated. The pancreas is cut from the pancreas neck, and the tumor is examined by freezing biopsy. The proximal plant is dissected and cut, and the pancreas uncinate process is released from the superior mesenteric artery and vein. Pancreaticojejunal anastomosis, hepaticojejunal anastomosis, gastrojejunal or duodenojejunal anastomosis are performed. In this case, anastomosis is performed by the method used by each institution.
Patient management after surgery
- preoperative : NRI(weight, albumin), BMI, Blood chemistry, Abdomen\&Pelvic Computed Tomography(APCT) (body composition calculation)
- 1day after surgery : blood chemistry, removal of nasogastric tube, water intake, early gate
- 2days after surgery : start diet (liquid or solid)
- 3days after surgery : blood chemistry, intravenous patient controlled analgesia removal, after 3 days, considering drain amylase and drain volume it can be removed.
- 5days after surgery : APCT
- 7days after surgery : NRI(weight, albumin), blood chemistry, tumor marker(if pathology is malignant)
- 14days after surgery : NRI(weight, albumin), blood chemistry
- 21days after surgery : NRI(weight, albumin), blood chemistry
- 3months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check)
- 6months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check)
- 12months after surgery : NRI(weight, albumin), blood chemistry, APCT(body composition check) ** Daily check amount of food intake from operation to discharge(Grade 1~3)
- Grade I: 30% or less of the provided amount can be consumed
- Grade II: 30~50% of the provided amount can be consumed
- Grade III: 50% or more of the provided amount can be consumed
- Nutritional risk index (NRI) was calculated using the following formula: NRI = (1.519 × serum albumin g/L) + 0.417 × (present weight/usual weight) × 100, with usual weight being the value measured during preoperative evaluation period
- Conditions
- Pancreaticoduodenectomy, Delayed Gastric Emptying, Nutrition
- Being tested
- Pylorus resecting pancreaticoduodenectomy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pylorus resecting pancreaticoduodenectomyProcedure or surgery
The patients in pylorus resection group will underwent pylorus resecting procedure during pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| pylorus resecting group | Experimental | The patients who underwent pylorus resecting pancreaticoduodenectomy for periampullary tumors Receives: Procedure: Pylorus resecting pancreaticoduodenectomy |
| pylorus preserving group | No intervention | The patients who underwent pylorus preserving pancreaticoduodenectomy for periampullary tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed gastric emptying
Delayed gastric emptying(DGE) is defined by International Study Group of Pancreas Surgery(ISGPS) definition.
- Grade A DGE should be considered if the Nasogastric tube(NGT) is required between the Postoperative Day(POD) 4 and 7, or if reinsertion of the NGT was necessary owing to nausea and vomiting after removal by POD 3 and the patient is unable to tolerate a solid diet on POD 7, but resumes a solid diet before Postoperative Day(POD)14 Grade B DGE is present if the NGT is required from POD 8-14, if reinsertion of the NGT was necessary after POD 7, or if the patient cannot tolerate unlimited oral intake by Postoperative Day(POD)14, but is able to resume a solid oral diet before POD 21 * Grade C DGE is present when nasogastric intubation cannot be discontinued or has to be reinserted after POD 14, or if the patient is unable to maintain unlimited oral intake by POD 21
Measured: up to 1 months
Secondary outcomes (2)
Nutritional risk index(NRI)
Nutritional risk index (NRI) is calculated using the following formula: NRI = (1.519 × serum albumin g/L) + 0.417 × (present weight/usual weight) × 100, with usual weight being the value measured during preoperative evaluation period
Measured: up to 12 months
Sarcopenia
Body composition, including Skeletal muscle area(SMA), Subcutaneous fat area(SFA), Visceral fat area(VFA) is calculated by axial CT slice at the L3 vertebral inferior endplate level
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion28 Apr 2024 (estimated)
- Study completion28 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Cheol Kim, Asan Medical Center
- Investigators
- Song-Cheol Kim, MD-PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314244
- Sponsor's protocol ID
- DGE_2022
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Postoperative Delayed Gastric Emptying and Nutritional Status
- ClinicalTrials.gov ID
- NCT05314244
- Acronym / sponsor ID
- DGE_2022
- Conditions
- Pancreaticoduodenectomy, Delayed Gastric Emptying, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 28 Apr 2024 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 6 Apr 2022 (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.
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. Recently, pylorus resecting pancreaticoduodenectomy has been actively performed because some studies reported that the procedure can reduce postoperative delayed gastric emptying.
However, the level of evidence is low and there was few studies considering nutritional status after pylorus resecting pancreaticoduodenectomy.
The purpose of this study is to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status.
Detailed description
Pylorus preserving pancreaticoduodenectomy has been standard procedure for periampullary benign and malignant disease. Delayed gastric emptying is one of most common complications after the procedure. It can lead to delay initiation of adjuvant chemotherapy as well as postoperative recovery. Since 2010, pylorus resecting pancreaticoduodenectomy was introduced to reduce postoperative delayed gastric emptying. The cases have been actively increased. However, several prospective randomized controlled trials reported pylorus resection during pancreaticoduodenectomy did not reduce the incidence or severity of delayed gastric emptying. Recent meta-analysis also showed same results.
Previous randomized controlled trials were single center studies participating a relatively small number of patients. A large-scale multicenter study is needed to obtain high level of evidence. And nutritional difference may appear between pylorus preservation and resection groups. Few studies have dealt with nutritional status between two groups.
- This study aimed to compare between pylorus-resecting and preserving pancreaticoduodenectomy on postoperative delayed gastric emptying and nutritional status in 5 tertiary referral centers in Korea..
- A case of pancreaticoduodenectomy with periampullary benign and malignant tumors will be included. The expected number of patients is 394. The pylorus resecting group was performed in the experimental group and the pylorus preserving group was performed in control group.
This clinical study is a randomized prospective comparative study of the outcome of pylorus resecting and preserving pancreatoduodenectomy, and the research hypothesis is as follows.
- Nursing Hypothesis: There is no difference in incidence of delayed gastric emptying between patients who underwent pylorus resecting pancreaticoduodenectomy and patients who underwent pylorus preserving surgery.
- Alternative Hypothesis: Based on the results of the same operation of the existing institution, the average incidence of delayed gastric emptying for pylorus preserving pancreaticoduodenectomy is estimated to be 20%, and the average incidence of delayed gastric emptying for pylorus resecting pancreaticoduodenectomy is estimated to be 10%.
The random assignment of this study is assigned according to the order of assignment in the planning stage of the study as a block randomization scheme with appropriate block size set.
- Plan for recruitment of research subjects : All patients scheduled for open pancreaticoduodenectomy for pancreatic or periampullary lesions will be explained about this study and will be selected after informed consent.
- Operative method : Both patients underwent conventional open pancreaticoduodenectomy with or without pylorus resection. In the experimental group, stomach resection was performed 1.0cm proximal to pylorus. In the control group, duodenal resection was performed 2.0cm distal to pylorus. Both groups are performed through the same surgical procedure except pylorus preservation or resection and the procedure is as follows. Kocher maneuver is performed to mobilize the duodenum. Omentectomy is performed and the gastrocolic truck is identified and ligated. The stomach or duodenum is cut off using an automatic stapler. A cholecystectomy is performed. The bile duct is cut and the frozen section is checked to confirm whether the tumor is invaded. The hepatic and hepatic arteries are dissected and the surrounding lymph nodes are dissected. The gastroduodenal artery is detached and ligated. The pancreas is cut from the pancreas neck, and the tumor is examined by freezing biopsy. The proximal plant is dissected and cut, and the pancreas uncinate process is released from the superior mesenteric artery and vein. Pancreaticojejunal anastomosis, hepaticojejunal anastomosis, gastrojejunal or duodenojejunal anastomosis are performed. In this case, anastomosis is performed by the method used by each institution.
Patient management after surgery
- preoperative : NRI(weight, albumin), BMI, Blood chemistry, Abdomen\&Pelvic Computed Tomography(APCT) (body composition calculation)
- 1day after surgery : blood chemistry, removal of nasogastric tube, water intake, early gate
- 2days after surgery : start diet (liquid or solid)
- 3days after surgery : blood chemistry, intravenous patient controlled analgesia removal, after 3 days, considering drain amylase and drain volume it can be removed.
- 5days after surgery : APCT
- 7days after surgery : NRI(weight, albumin), blood chemistry, tumor marker(if pathology is malignant)
- 14days after surgery : NRI(weight, albumin), blood chemistry
- 21days after surgery : NRI(weight, albumin), blood chemistry
- 3months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check)
- 6months after surgery : NRI(weight, albumin), blood chemistry, APCT (body composition check)
- 12months after surgery : NRI(weight, albumin), blood chemistry, APCT(body composition check) ** Daily check amount of food intake from operation to discharge(Grade 1~3)
- Grade I: 30% or less of the provided amount can be consumed
- Grade II: 30~50% of the provided amount can be consumed
- Grade III: 50% or more of the provided amount can be consumed
- Nutritional risk index (NRI) was calculated using the following formula: NRI = (1.519 × serum albumin g/L) + 0.417 × (present weight/usual weight) × 100, with usual weight being the value measured during preoperative evaluation period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pylorus resecting group | Experimental | Procedure: Pylorus resecting pancreaticoduodenectomyThe patients who underwent pylorus resecting pancreaticoduodenectomy for periampullary tumors |
| pylorus preserving group | No intervention | –The patients who underwent pylorus preserving pancreaticoduodenectomy for periampullary tumors |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 to 79 years
- Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
- The preoperative examination showed that the lesion could invade to major artery.
- No distant metastasis
- Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3
Key exclusion criteria (12 listed)
- Patients diagnosed with duodenal cancer
- Those with active or uncontrolled infections
- Those with severe psychiatric / neurological disorders
- Alcohol or other drug addicts
- Patients who underwent previous major abdominal surgery (ex. gastrectomy, colectomy)
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 |
|---|---|---|
| Pylorus resecting pancreaticoduodenectomyThe patients in pylorus resection group will underwent pylorus resecting procedure during pancreaticoduodenectomy | Procedure or surgery | pylorus resecting group |
Primary outcome
Incidence of delayed gastric emptying
Time frame: up to 1 months
Delayed gastric emptying(DGE) is defined by International Study Group of Pancreas Surgery(ISGPS) definition. * Grade A DGE should be considered if the Nasogastric tube(NGT) is required between the Postoperative Day(POD) 4 and 7, or if reinsertion of the NGT was necessary owing to nausea and vomiting after removal by POD 3 and the patient is unable to tolerate a solid diet on POD 7, but resumes a solid diet before Postoperative Day(POD)14 Grade B DGE is present if the NGT is required from POD 8-14, if reinsertion of the NGT was necessary after POD 7, or if the patient cannot tolerate unlimited oral intake by Postoperative Day(POD)14, but is able to resume a solid oral diet before POD 21 * Grade C DGE is present when nasogastric intubation cannot be discontinued or has to be reinserted after POD 14, or if the patient is unable to maintain unlimited oral intake by POD 21
2 secondary outcomes
Nutritional risk index(NRI)
Time frame: up to 12 months
Sarcopenia
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- 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.
Song-Cheol Kim, MD-PhD principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Pylorus resecting pancreaticoduodenectomy in people with Pancreaticoduodenectomy and Delayed Gastric Emptying, run by Asan Medical Center.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bong Jun Kwak, MD (+82-10-4519-0280, iio1000@nate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delayed gastric emptying (time frame: up to 1 months). 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 6 Apr 2022.