Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Delayed Gastric Emptying and Nutrition

NCT05314244 | Unknown DMC

• 1 other identifier: DGE_2022
• Study Type: interventional
• Target: 394
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pancreaticoduodenectomy; Delayed Gastric Emptying; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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

  up to 1 months

Secondary Outcomes (2)

• Nutritional risk index(NRI)

  up to 12 months

• Sarcopenia

  up to 12 months

Study Arms (2)

pylorus resecting group

EXPERIMENTAL

The patients who underwent pylorus resecting pancreaticoduodenectomy for periampullary tumors

Procedure: Pylorus resecting pancreaticoduodenectomy

pylorus preserving group

NO INTERVENTION

The patients who underwent pylorus preserving pancreaticoduodenectomy for periampullary tumors

Interventions

Pylorus resecting pancreaticoduodenectomy PROCEDURE

The patients in pylorus resection group will underwent pylorus resecting procedure during pancreaticoduodenectomy

pylorus resecting group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Asan Medical Center: lead

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Song-Cheol Kim, MD-PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bong Jun Kwak, MD

CONTACT

+82-10-4519-0280; iio1000@nate.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: May 1, 2022
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2025
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share