Impact of Additional DJ (Duodenojejunostomy)-Pexy on Reduction in Delayed Gastric Emptying Following Pylorus-preserving Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial

NCT ID: NCT02635399

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-12-31

Brief Summary

Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most important modality in the treatment. In the past, pancreaticoduodenectomy was associated with high morbidity and mortality. However, with the advances in techniques, including perioperative patient management, development of antibiotics, diagnostic radiology, and interventional treatments, pancreaticoduodenectomy is now considered a safe and feasible operation. Postoperative complication rates are reported to be in 10 to 20% in experienced hospitals and operation related mortality is at about 1%. Therefore, surgical treatment for periampullary cancer is actively considered.

However, postoperative complications, such as postoperative pancreatic fistula, (POPF) delayed gastric emptying, intraabdominal abscess, and postoperative bleeding, are still serious complications. Among these complications, delayed gastric emptying is considered less critical. However, delayed gastric emptying (DGE) can cause poor oral intake, which in turn, may lead to delay in recovery of postoperative nutritional state and in severe cases, requires insertion of levine tube and long-term fasting.

There have been many hypotheses for cause of DGE after pancreaticoduodenectomy, but definite cause have not been discovered yet. With the introduction of pylorus-preserving pancreaticoduodenectomy (PPPD), incidences of DGE were initially reported to have increased. However, results of most randomized comparative studies had concluded that PPPD and PD have no significance in occurence of DGE.

One hypothesis for cause of DGE we present here has to do with anatomic positioning of anastomosis site, especially pancreatojejunostomy (PJ) and duodenojejunostomy (DJ), after PPPD. Reconstruction after PPPD positions PJ and DJ close to each other. PJ site is often associated with one of postoperative complications, POPF. POPF may create inflammation around PJ site and pancreatitis, which may lead to severe adhesion around PJ as a secondary change. This adhesion and inflammation may cause DJ, which is located near PJ, to be pulled towards PJ site. When DJ is pulled towards PJ site, distal DJ site can become angulated and gastric contents may not beadle to pass easily. Gastric contents may be stagnated in stomach and thereby causing DGE. Therefore, in this study, we will fixate DJ on transverse colon using sutures, and prevent possibility of angulation of DJ. This additional procedure may reduce occurence of DGE.

Conditions

Delayed Gastric Emptying

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

conventional group

Conventional PPPD

Group Type: PLACEBO_COMPARATOR

PPPD (pylorus-preserving pancreaticoduodenectomy)

Intervention Type: PROCEDURE

pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.

DJ-pexy group

PPPD with additional DJ-pexy to anchor DJ to transverse colon

Group Type: EXPERIMENTAL

PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy

Intervention Type: PROCEDURE

pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.

Interventions

PPPD (pylorus-preserving pancreaticoduodenectomy)

pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.

Intervention Type: PROCEDURE

PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy

pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All periampullary pathologic conditions that require PPPD
• Age ≥20 and ≤80
• General performance status: the Karnofsky score> 70% or ECOG 0-1

Exclusion Criteria

• Unresectable or locally advanced, metastatic case
• patients who do not want surgery
• ASA (American society of anesthesiologists' physical status classification) score: ≥3
• patients with drug or alcohol addiction
• patients showing low compliance
• patients who not want to involve the clinical trial
• patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
• pylorus can not be preserved
• Patients undergoing laparoscopic PPPD
• Additional resection of adjacent organs or vascular resection was performed
• Previous history of open surgery

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Chang Moo Kang, MD

Role: primary

cmkang@yuhs.ac

82-2-2228-2100

References

Khan AS, Hawkins WG, Linehan DC, Strasberg SM. A technique of gastrojejunostomy to reduce delayed gastric emptying after pancreatoduodenectomy. J Gastrointest Surg. 2011 Aug;15(8):1468-71. doi: 10.1007/s11605-011-1471-4. Epub 2011 Feb 24.

Reference Type: BACKGROUND

PMID: 21347870 (View on PubMed)

Other Identifiers

4-2015-0969

Identifier Type: -

Identifier Source: org_study_id