Post-Cholecystectomy Gall Bladder Remnant and Cystic Duct Stump Stone

March 31, 2020 updated by: Tamer Alsaied Alnaimy, Zagazig University

Post-Cholecystectomy Gall Bladder Remnant and Cystic Duct Stump Stone: Surgical Pitfalls, Causes of Occurrence and Completion Cholecystectomy (Open Vs Laparoscopic) as a Safe Surgical Option of Treatment

Introduction: cholecystectomy relieves pre-surgical symptoms of gallbladder disease. The persistence of symptoms was recorded in 10 - 20% of cases. Residual gall bladder/cystic duct stump stone is one of the most important cause.

Aim: to compare between open and laparoscopic completion cholecystectomy of gall bladder remnant and cystic duct stump syndrome as regard short and long term outcome.

Methods: This prospective study was conducted on 20 cases with residual GB/cystic duct stump stone. The diagnosis was guided by ultrasound and magnetic resonance cholangio-pancreatography. All cases were managed by using completion cholecystectomy - either open or laparoscopic. All preoperative, operative, and postoperative data were collected...

Study Overview

Detailed Description

The incidence of gall bladder and cystic duct stump stones has been reported to be 5% of patients after urgent cholecystectomy, and it is rare after elective operations . The incidence of incomplete gallbladder removal following laparoscopic cholecystectomy is 13.3% . Partial cholecystectomy may be resorted to in many conditions such as difficult dissection in Calot's triangle that can be hazardous to common bile duct and/or blood vessels. In such cases, many surgeons leave a part of the gall bladder in the manner described by author after removing all stones from the remaining cuff of the gallbladder To prevent the incidence of gallbladder remnant/cystic duct stump calculi, the cystic duct should be fully skeletonized till 1 cm from the common bile duct. Stones in the cystic duct should be milked back to the gallbladder before clipping Routine use of intraoperative cholangiography is not a must but when used it can be useful in detecting calculi in the cystic duct The diagnosis of cystic duct stump syndrome is always into the dilemma of post cholecystectomy syndromes and leads to delayed diagnosis. Cystic duct stump syndrome may be misdiagnosed with reflux esophagitis, peptic ulceration, irritable bowel syndrome or chronic pancreatitis hepatitis, mesenteric ischemia, diverticulitis, and organic or motor intestinal disorders.

The imaging approach to post cholecystectomy syndrome includes ultrasonography, computed tomography (CT) scan, endoscopic retrograde cholangiopancreatography (ERCP), and magnetic resonance cholangiopancreatography (MRCP).

The purpose of this study is to emphasis that laparoscopic completion cholecystectomy is the best surgical option for cystic duct stump and gall bladder remnant syndrome as regard safety to the patients...

There may be gender specific risk factor for developing post-cholecystectomy syndrome, in present study; the incidence was 70% in females (14 cases) compared to 30% in males (6 cases). This higher incidence in females was also reported , whom stated that the male to female ratio was 1:1.45.

The symptoms of gall bladder syndrome may be nil or they can present with acute symptoms (biliary colic, acute cholecystitis or acute pancreatitis) or chronic symptoms (persistent right upper quadrant discomfort or pain, food intolerance, nausea or jaundice). The persistence of symptoms after cholecystectomy points to the possibility of a gallbladder remnant, especially when coupled with radiation of pain to the shoulder, food intolerance, nausea or jaundice . abdominal pain and persistent dyspepsia as the commonest presentation were stated by other study , while , reported that patients was referred to their institution without persistent symptoms after cholecystectomy .In the present study, most cases presented with right hypochondrial pain (18 cases) and asymptomatic cases are 2 cases and discovered accidently by ultrasonography for other unrelated symptoms.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Age: 30-50

    • Both sex
    • Previous cholecystectomy(open or laparoscopic)
    • With or without common bile duct stone.
    • Symptomatic or

Exclusion Criteria:

  • • 1-patients unfit for surgery

    • 2-patient refused surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open completion cholecystectomy
open completion cholecystectomy for cystic duct stump stone
open excision of cystic duct remnant
Active Comparator: laparoscopic completion cholecystectomy
lap completion cholecystectomy for cystic duct stump stone
lap excision of cystic duct stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain severity on visual analogue score
Time Frame: 2 weeks
assessement of pain severity after operation in record of 10
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative time in minutes
Time Frame: 2 hours
assessement of time in the operation in minutes
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: tamer A. alnaimy, MD, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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