Efficacy of Hemi-double-stapling Technique

Pylorus-preserving Pancreaticoduodenectomy Using a Hemi-double-stapling Technique

Surgical stapler is used in all areas of surgical operation. Surgical stapler has been used in various surgical fields for a long time, so its stability has already been proven. After gastrectomy or colectomy, the hemi-double stapling technique, which is an improved double stapling technique, has been applied as an anastomosis method using a stapler.

In the duodenojejunal anastomosis after PPPD, the hemi-double stapling method can be applied to preserve the pyloric branch of the vagus nerve and the branch of the right gastric artery to ensure sufficient blood supply. Ultimately, it is expected to shorten the anastomosis time as well as reduce the frequency of delayed gastric emptying. In addition, the work of physically expanding the pylorus to insert the circular anastomosis is also thought to reduce gastric emptying delay.

Study Overview

• Status: Recruiting
• Conditions: Periampullar Disease
• Intervention / Treatment: Procedure: Hand-sewn; Procedure: Hemi-double stapling

Detailed Description

(1) Stapling technique

1. Make purse-string suture on jejunum at the point of duodenojejunostomy
2. Insert Anvil into jejunem
3. Make incision of 3-4 centimeters at anterior side of antrum
4. Long Kelly forceps are inserted into the stomach to dilate the pylorus
5. A 25 mm end-to-end anastomosis (EEA) stapler is inserted into the stomach and passed through the pylorus.
6. The needle of EEA stapler is pierced through the lower part of the stapler line where the duodenum has been resected
7. The EEA stapler is combined with the anvil and anastomosis is performed
8. The incision on the stomach is sutured through a linear stapler
9. Reinforcement suture for stapler line

(2) Postoperative management

• Diet build up as same manner of hand-sewn group (3) Postoperative follow-up
• All postoperative complication, delayed gastric emptying, intraperitoneal abscess, postoperative pancreatic fistula, postpancreatectomy hemorrhage, hospital stay, reoperation, readmission and 2-months mortality.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joon Seoung Park; Phone Number: 82-2-2019-2444; Email: jspark330@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: JoonSeoung Park; Phone Number: 82-2-2019-2999; Email: JSPARK330@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. pylorus-preserving pancreaticoduodenectomy
2. ECOG scale 0-1
3. Age > 19
4. Appropriate organ function as below i.WBC : ≥2500 mm3, ≤14000 mm3 ii.Hemoglobin : ≥9.0 g/dL iii.Platelet : ≥100,000 mm3 iv.Total bilirubin : ≤2.0 mg/dL (except for occlusive jaundice) v.Creatinine : ≤2.0 mg/dL
5. patient who can understand and sign the informed consent

Exclusion Criteria:

1. previous history of gastrectomy
2. ulcerative scar around ampulla of duodenum on endoscopy
3. previous history of upper abdomen surgery (open)
4. Emergency
5. Severe ischemic heart disease
6. Severe hepatic failure by liver cirrhosis or hepatitis
7. Severe respiratory failure that requires oxygene inhalation
8. Chronic renal failure that requires hemodialysis
9. Expecting combine resection of other organ
10. Immunosuppressive therapy
11. Accompanying cancer with potential for adverse events
12. Severe psychologic or neurologic disease
13. drug or alcohol addiction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I (Hand-sewn group); Doudenojejunal anastomosis by hand-swen method	Procedure: Hand-sewn; Doudenojejunal anastomosis by hand-sewn method
Active Comparator: II (Stapling group); Doudenojejunal anastomosis by hemi-double-stapling method	Procedure: Hemi-double stapling; Doudenojejunal anastomosis by hemi-double-stapling method "EEA25 - Covidien EEA Circular Stapler DST Series 25.0mm x 4.8mm" is used for anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of delayed gastric emptying by ISGPS	Delayed gastric emptying will be evaluated at postoperative 21 day using International study group of pancreatic surgery (ISGPS) classification. According to ISGPS classification, delayed gastric emptying is divided into three grades from A to C. Grade C means worse than grade A.-->Unit of Measure: Grade A,B,C	At postoperative 21 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital stay	Duration (days) of hospital stay, which means interval between operation day and discharge day will be checked up to postoperative 2 months. --> Unit of Measure: days	At postoperative 21 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraperitoneal abscess	Intraperitoneal abscess will be evaluated using 2 point scale (yes or no) at postoperative 2 months.; Unit of Measure: Yes, No	at postoperative 2 months
Incidence of reoperation/ readmission	The incidence of reoperation and readmission will be evaluated using 2 point scale (yes or no) at postoperative 2 months.--> Unit of Measure: Yes, No	At postoperative 21 day

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Joon Seoung Park, GangnamSeverance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Anticipated): April 22, 2024
• Study Completion (Anticipated): April 22, 2024

Study Registration Dates

• First Submitted: August 8, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 3-2021-0084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No